A Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Study identifier:CD-IA-CAM-3001-1107

ClinicalTrials.gov identifier:NCT01715896

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2 Exploratory Study of Mavrilimumab versus Anti-tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Medical condition

Rheumatoid Arthritis

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

215

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Mar 2013

Primary Completion Date: 01 Nov 2014

Study Completion Date: 01 Feb 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

St. Petersburg, Russian Federation

Location

Research Site

Barcelona, Spain

Location

Research Site

Kazan, Russian Federation

Location

Research Site

Bilbao, Spain

Location

Research Site

Baja, Hungary

Location

Research Site

Balatonfured, Hungary

Location

Research Site

Praha 2, Czech Republic

Location

Research Site

Malaga, Spain

Arms	Assigned Interventions
Experimental: Golimumab 50 mg alternating with Placebo Participants received alternating doses of golimumab 50 milligram (mg) (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.	Biological/Vaccine: Golimumab 50 mg Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Experimental: Mavrilimumab 100 mg Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.	Biological/Vaccine: Mavrilimumab 100 mg Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route. Other Name: CAM-3001

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall, 215 participants were screened, of which 77 participants were considered as screen failures and 138 participants were randomized and completed in the study.

Reporting Groups

	Description
Golimumab 50 milligram (mg) alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Participant Flow: Overall Study

	Golimumab 50 milligram (mg) alternating with Placebo	Mavrilimumab 100 mg
STARTED	68	70
COMPLETED	65	59
NOT COMPLETED	3	11
Lost to Follow-up	0	2
Withdrawal by Subject	1	4
Unspecified	2	5

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The modified intent to treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 milligram (mg) alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Baseline Measures

	Golimumab 50 milligram (mg) alternating with Placebo	Mavrilimumab 100 mg	Total
Number of Participants [units: Participants]	68	70	138
Age Continuous [units: years] Mean ± Standard Deviation	49.9 ± 11.4	50.2 ± 13.3	50.0 ± 12.4
Gender, Male/Female [units: Participants]
Female	57	56	113
Male	11	14	25

Outcome Measures

1. Primary Outcome Measure: Percentage of Participants who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 [ Time Frame: Day 169 ]

Measure Type	Primary
Measure Name	Percentage of Participants who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
Measure Description	The ACR20 was defined as greater than or equal to (>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 [units: percentage of participants]	65.6	62.0

Statistical Analysis 1 for Percentage of Participants who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Logit response Model]
P-Value^[4]	0.666
Other^[5]	-3.5
90% Confidence Interval	( -16.8 to 9.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.

2. Primary Outcome Measure: Percentage of Participants who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 [ Time Frame: Day 169 ]

Measure Type	Primary
Measure Name	Percentage of Participants who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
Measure Description	The ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 [units: percentage of participants]	43.4	34.8

Statistical Analysis 1 for Percentage of Participants who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Logit response Model]
P-Value^[4]	0.293
Other^[5]	-8.6
90% Confidence Interval	( -22.0 to 4.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.

3. Primary Outcome Measure: Percentage of Participants who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 [ Time Frame: Day 169 ]

Measure Type	Primary
Measure Name	Percentage of Participants who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
Measure Description	The ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 [units: percentage of participants]	25.9	16.1

Statistical Analysis 1 for Percentage of Participants who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Logit Response Model]
P-Value^[4]	0.156
Other^[5]	-9.8
90% Confidence Interval	( -21.1 to 1.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.

4. Primary Outcome Measure: Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 [ Time Frame: Day 169 ]

Measure Type	Primary
Measure Name	Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169
Measure Description	The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 [units: percentage of participants]	29.0	17.4

Statistical Analysis 1 for Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Logit Response Model ]
P-Value^[4]	0.108
Other^[5]	-11.6
90% Confidence Interval	( -23.2 to 0.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.

5. Primary Outcome Measure: Percentage of Participants who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement from Baseline and >= 0.25 at Day 169 [ Time Frame: Day 169 ]

Measure Type	Primary
Measure Name	Percentage of Participants who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement from Baseline and >= 0.25 at Day 169
Measure Description	The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement from Baseline and >= 0.25 at Day 169 [units: percentage of participants]	69.0	58.7

Statistical Analysis 1 for Percentage of Participants who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement from Baseline and >= 0.25 at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Logit Response Model]
P-Value^[4]	0.2080
Other^[5]	-10.3
90% Confidence Interval	( -23.7 to 3.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.

6. Secondary Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Baseline up to Day 169 ]

Measure Type	Secondary
Measure Name	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Measure Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.
Time Frame	Baseline up to Day 169
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any amount of study medication.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [units: participants]
TEAEs	29	36
TESAEs	3	2
Investigational-product-related TEAE	11	12
Severe TEAE	3	1
Acute TEAEs	7	5
Acute Severe TEAE	1	0
Investigational-product-related TESAE	2	0

No statistical analysis provided for Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

7. Secondary Outcome Measure: Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 169 ]

Measure Type	Secondary
Measure Name	Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Measure Description	Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.
Time Frame	Baseline up to Day 169
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any amount of investigational product.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) [units: participants]
Leukocytosis	0	2
Neutropenia	1	0
Anaemia of chronic disease	1	0
Alanine aminotransferase increased	2	0
Blood parathyroid hormone increased	0	1
Gamma-glutamyltransferase increased	1	0
Hepatic enzyme increased	2	3
Dyslipidaemia	2	0
Hypercholesterolaemia	2	0
Hyperglycaemia	0	1
Hyperlipidaemia	0	1
Hypertriglyceridaemia	0	1
Urinalysis	0	0

No statistical analysis provided for Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)

8. Secondary Outcome Measure: Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 169 ]

Measure Type	Secondary
Measure Name	Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Measure Description	Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.
Time Frame	Baseline up to Day 169
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any amount of study medication.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) [units: participants]
Hypertension	0	1
Pyrexia	2	0

No statistical analysis provided for Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

9. Secondary Outcome Measure: Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169 [ Time Frame: Day 85 and 169 ]

Measure Type	Secondary
Measure Name	Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169
Measure Description	Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (>) 20% reduction (RD) and absolute value (AV) less than (<) 80% predicted (PR).
Time Frame	Day 85 and 169
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any amount of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169 [units: participants]
Day 85: FEV1 > 20% RD (n=64, 63)	1	0
Day 169: FEV1 > 20% RD (n=64, 64)	4	1
Day 85: FEV1 > 20% RD and AV < 80% PR (n=64, 63)	1	0
Day 169: FEV1 > 20% RD and AV < 80% PR (n=64, 64)	4	1
Day 85: FEV6 > 20% RD (n=54, 55)	1	1
Day 169: FEV6 > 20% RD (n=54, 56)	4	0
Day 85: FEV6 > 20% RD and AV < 80% PR (n=54, 55)	0	1
Day 169: FEV6 > 20% RD and AV < 80% PR (n=54, 56)	2	0
Day 85: FVC > 20% RD (n=64, 63)	0	0
Day 169: FVC > 20% RD (n=64, 64)	2	1
Day 85: FVC > 20% RD and AV < 80% PR (n=64, 63)	0	0
Day 169: FVC > 20% RD and AV < 80% PR (n=64, 64)	2	1
Day 85: DLCO > 15-20% RD (n=18, 21)	1	0
Day 169: DLCO > 15-20% RD (n=22, 23)	0	0
Day 85: DLCO > 20% RD (n=18, 21)	1	0
Day 169: DLCO > 20% RD (n=22, 23)	1	0

No statistical analysis provided for Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169

10. Secondary Outcome Measure: Dyspnea Score at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Dyspnea Score at Day 169
Measure Description	Borg dyspnea scale was a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.
Time Frame	Day 169
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received any amount of investigational product. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	64	63
Dyspnea Score at Day 169 [units: units on a scale] Mean (Standard Deviation)	0.34 (0.81)	0.42 (0.73)

No statistical analysis provided for Dyspnea Score at Day 169

11. Secondary Outcome Measure: Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169 [ Time Frame: Baseline and Day 169 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169
Measure Description	DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission.
Time Frame	Baseline and Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169 [units: units on a scale] Mean (Standard Deviation)
Baseline (n=68, 70)	5.72 (0.83)	5.82 (0.96)
Day 169 (n=62, 62)	-2.40 (1.42)	-2.11 (1.30)

No statistical analysis provided for Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169

12. Secondary Outcome Measure: Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169 [ Time Frame: Baseline up to Day 169 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169
Measure Description	ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).
Time Frame	Baseline up to Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169 [units: units on a scale] Mean (Standard Error)	40.49 (5.406)	33.06 (5.199)

Statistical Analysis 1 for Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.213
Other^[5]	-7.42
90% Confidence Interval	( -17.24 to 2.40 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.

13. Secondary Outcome Measure: American College of Rheumatology (ACR) Hybrid Score at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	American College of Rheumatology (ACR) Hybrid Score at Day 169
Measure Description	ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
American College of Rheumatology (ACR) Hybrid Score at Day 169 [units: units on a scale] Median (Full Range)	49.99 (-9.0 to 98.2)	41.66 (-1.0 to 90.3)

No statistical analysis provided for American College of Rheumatology (ACR) Hybrid Score at Day 169

14. Secondary Outcome Measure: Number of Participants who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Number of Participants who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
Measure Description	DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Number of Participants who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169 [units: participants]
No response	12	16
Moderate response	28	35
Good response	28	19

Statistical Analysis 1 for Number of Participants who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Proportional odds analysis]
P-Value^[4]	0.129
Odds Ratio (OR)^[5]	0.61
90% Confidence Interval	( 0.36 to 1.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.

15. Secondary Outcome Measure: Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
Measure Description	DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169 [units: participants]
DAS28 (CRP) Remission	20	12
Low Disease Activity	28	20

Statistical Analysis 1 for Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	0.108
Other^[5]	-11.6
90% Confidence Interval	( -23.2 to 0.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.

Statistical Analysis 2 for Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	0.145
Other^[5]	-11.7
90% Confidence Interval	( -24.8 to 1.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The analysis reported DAS28 (CRP) low disease activity response.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.

16. Secondary Outcome Measure: Time to Onset DAS28 (CRP) remission at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Time to Onset DAS28 (CRP) remission at Day 169
Measure Description	The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, "N" is number of participants analysed for this outcome measure.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	20	12
Time to Onset DAS28 (CRP) remission at Day 169 [units: days] Median (90% Confidence Interval)	57.0 (29.0 to 112.0)	113.0 (57.0 to 141.0)

Statistical Analysis 1 for Time to Onset DAS28 (CRP) remission at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Log Rank
P-Value^[4]	0.328

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	P-value was calculated using the Log rank test.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

17. Secondary Outcome Measure: Duration of DAS28 (CRP) Remission at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Duration of DAS28 (CRP) Remission at Day 169
Measure Description	The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, "N" is number of participants analysed for this outcome measure.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	20	12
Duration of DAS28 (CRP) Remission at Day 169 [units: days] Mean (Standard Error)	105.0 (0.24)	69.6 (0.15)

Statistical Analysis 1 for Duration of DAS28 (CRP) Remission at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Weibull model]
P-Value^[4]	0.003

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	P-value was calculated using an Weibull model.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

18. Secondary Outcome Measure: Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169
Measure Description	The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. The percentage of participants were calculated by logistic regression model method.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169 [units: percentage of participants]	19.0	17.3

Statistical Analysis 1 for Percentage of Participants who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	0.795
Other^[5]	-1.7
90% Confidence Interval	( -12.4 to 9.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.

19. Secondary Outcome Measure: Percentage of Participants who Achieved Simplified Disease Activity Index (SDAI) remission at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Percentage of Participants who Achieved Simplified Disease Activity Index (SDAI) remission at Day 169
Measure Description	The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants who Achieved Simplified Disease Activity Index (SDAI) remission at Day 169 [units: percentage of participants]	18.9	7.2

Statistical Analysis 1 for Percentage of Participants who Achieved Simplified Disease Activity Index (SDAI) remission at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	0.048
Other^[5]	-11.7
90% Confidence Interval	( -21.0 to -2.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.

20. Secondary Outcome Measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
Measure Description	The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169 [units: percentage of participants]	17.6	5.7

Statistical Analysis 1 for Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	0.035
Other^[5]	-11.9
90% Confidence Interval	( -20.6 to -3.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.

21. Secondary Outcome Measure: Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
Measure Description	The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169 [units: percentage of participants]	8.9	1.4

Statistical Analysis 1 for Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	0.061
Other^[5]	-7.5
90% Confidence Interval	( -13.6 to -1.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.

22. Secondary Outcome Measure: Mean Change From Baseline in Swollen and Tender Joint Count at Day 169 [ Time Frame: Baseline and Day 169 ]

Measure Type	Secondary
Measure Name	Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
Measure Description	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.
Time Frame	Baseline and Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Mean Change From Baseline in Swollen and Tender Joint Count at Day 169 [units: joint count] Mean (Standard Error)
SJC: Baseline (n=68, 70)	14.49 (0.779)	14.07 (0.824)
SJC: Change at Day 169 (n=64, 64)	-10.07 (0.777)	-10.08 (0.747)
TJC: Baseline (n=68, 70)	24.93 (1.662)	25.04 (1.543)
TJC: Change at Day 169 (n=64, 64)	-15.42 (1.457)	-14.19 (1.399)

Statistical Analysis 1 for Mean Change From Baseline in Swollen and Tender Joint Count at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.993
Other^[5]	-0.01
90% Confidence Interval	( -1.33 to 1.32 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis reported for change from baseline in swollen joint count at Day 169.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.

Statistical Analysis 2 for Mean Change From Baseline in Swollen and Tender Joint Count at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.424
Other^[5]	1.23
90% Confidence Interval	( -1.31 to 3.77 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis reported for change from baseline in Tender joint count at Day 169.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.

23. Secondary Outcome Measure: Mean Change From Baseline in Patient Assessment of Pain at Day 169 [ Time Frame: Baseline and Day 169 ]

Measure Type	Secondary
Measure Name	Mean Change From Baseline in Patient Assessment of Pain at Day 169
Measure Description	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame	Baseline and Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Mean Change From Baseline in Patient Assessment of Pain at Day 169 [units: millimeter (mm)] Mean (Standard Error)
Baseline (n=68, 70)	66.93 (2.352)	69.81 (2.015)
Change at Day 169 (n=64, 64)	-29.61 (3.843)	-24.72 (3.727)

Statistical Analysis 1 for Mean Change From Baseline in Patient Assessment of Pain at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.272
Other^[5]	4.89
90% Confidence Interval	( -2.46 to 12.24 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.

24. Secondary Outcome Measure: Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169 [ Time Frame: Baseline and Day 169 ]

Measure Type	Secondary
Measure Name	Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
Measure Description	Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly.
Time Frame	Baseline and Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169 [units: mm] Mean (Standard Error)
Baseline (n=68, 70)	67.57 (2.219)	68.53 (2.212)
Change at Day 169 (n=64, 64)	-28.50 (3.773)	-24.04 (3.671)

Statistical Analysis 1 for Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.319
Other^[5]	4.46
90% Confidence Interval	( -2.92 to 11.84 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.

25. Secondary Outcome Measure: Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169 [ Time Frame: Baseline and Day 169 ]

Measure Type	Secondary
Measure Name	Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
Measure Description	Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.
Time Frame	Baseline and Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169 [units: centimeter (cm)] Mean (Standard Error)
Baseline (n=68, 70)	6.89 (0.159)	7.04 (0.169)
Change at Day 169 (n=64, 64)	-4.28 (0.317)	-4.11 (0.307)

Statistical Analysis 1 for Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.640
Other^[5]	0.16
90% Confidence Interval	( -0.42 to 0.74 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.

26. Secondary Outcome Measure: Mean Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169 [ Time Frame: Baseline and Day 169 ]

Measure Type	Secondary
Measure Name	Mean Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
Measure Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.
Time Frame	Baseline and Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Mean Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169 [units: units on a scale] Mean (Standard Error)
Baseline (n=68, 70)	1.58 (0.063)	1.59 (0.070)
Change at Day 169 (n=64, 64)	-0.59 (0.081)	-0.40 (0.078)

Statistical Analysis 1 for Mean Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.055
Other^[5]	0.18
90% Confidence Interval	( 0.03 to 0.34 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.

27. Secondary Outcome Measure: Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline [ Time Frame: Baseline and Day 169 ]

Measure Type	Secondary
Measure Name	Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline
Measure Description	The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.
Time Frame	Baseline and Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	64	64
Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline [units: ratio] Geometric Mean (Geometric Coefficient of Variation)	0.5036 (344.0%)	0.5142 (100.9%)

Statistical Analysis 1 for Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.752
Other^[5]	1.06
90% Confidence Interval	( 0.79 to 1.41 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.

28. Secondary Outcome Measure: Erythrocyte Sedimentation Rate (ESR) at Day 169 [ Time Frame: Day 169 ]

Measure Type	Secondary
Measure Name	Erythrocyte Sedimentation Rate (ESR) at Day 169
Measure Description	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.
Time Frame	Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure. "n'' signifies participants evaluable for specified category for each arm, respectively.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Erythrocyte Sedimentation Rate (ESR) at Day 169 [units: millimeter per hour (mm/h)] Geometric Mean (Standard Deviation)	26.8 (21.0)	27.8 (20.8)

Statistical Analysis 1 for Erythrocyte Sedimentation Rate (ESR) at Day 169

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [Repeated measures model]
P-Value^[4]	0.725
Other^[5]	1.05
90% Confidence Interval	( 0.84 to 1.30 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.

29. Secondary Outcome Measure: Serum Concentrations of Mavrilimumab [ Time Frame: Baseline, Day 8, 15, 29, 85, 141, and 169 ]

Measure Type	Secondary
Measure Name	Serum Concentrations of Mavrilimumab
Measure Description	Serum concentrations after subcutaneous dose of mavrilimumab were calculated
Time Frame	Baseline, Day 8, 15, 29, 85, 141, and 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here "n" signifies participants who were evaluable for the specified time point for each this arm respectively.

Reporting Groups

	Description
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	70
Serum Concentrations of Mavrilimumab [units: nanogram per milliliter (ng/mL)] Geometric Mean (Geometric Coefficient of Variation)
Baseline (n=69)	0.00 (512.9%)
Day 8 (n=66)	2837.24 (49.1%)
Day 15 (n=67)	1084.43 (143.6%)
Day 29 (n=69)	2094.70 (58.9%)
Day 85 (n=67)	2886.71 (64.1%)
Day 141 (n=63)	1731.65 (79.3%)
Day 169 (n=64)	1701.13 (67.9%)

No statistical analysis provided for Serum Concentrations of Mavrilimumab

30. Secondary Outcome Measure: Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab [ Time Frame: Day 1 to Day 169 ]

Measure Type	Secondary
Measure Name	Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab
Measure Description	Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.
Time Frame	Day 1 to Day 169
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Measured Values

	Golimumab 50 mg alternating with Placebo	Mavrilimumab 100 mg
Number of Participants Analyzed [units:participants]	68	70
Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab [units: participants]	3	3

No statistical analysis provided for Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab

Serious Adverse Events

Time Frame	Baseline up to Day 169
Additional Description	The safety population included all participants who received any amount of study medication.

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Serious Adverse Events

Golimumab 50 mg alternating with Placebo

Mavrilimumab 100 mg

Total, serious adverse events

# participants affected / at risk

3/68 (4.41%)

2/70 (2.86%)

Gastrointestinal disorders

Gastroduodenitis¹,^†

# participants affected / at risk

1/68 (1.47%)

0/70 (0.00%)

# events

Gastrointestinal disorders

Peptic ulcer¹,^†

# participants affected / at risk

1/68 (1.47%)

0/70 (0.00%)

# events

Infections and infestations

Pneumocystis jirovecii pneumonia¹,^†

# participants affected / at risk

1/68 (1.47%)

0/70 (0.00%)

# events

Investigations

Hepatic enzyme increased¹,^†

# participants affected / at risk

1/68 (1.47%)

0/70 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Parathyroid tumour benign¹,^†

# participants affected / at risk

0/68 (0.00%)

1/70 (1.43%)

# events

Nervous system disorders

Vertebrobasilar insufficiency¹,^†

# participants affected / at risk

0/68 (0.00%)

1/70 (1.43%)

# events

Respiratory, thoracic and mediastinal disorders

Lung disorder¹,^†

# participants affected / at risk

1/68 (1.47%)

0/70 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 17.1

Other Adverse Events

Time Frame	Baseline up to Day 169
Additional Description	The safety population included all participants who received any amount of study medication.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
Golimumab 50 mg alternating with Placebo	Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
Mavrilimumab 100 mg	Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Other Adverse Events

Golimumab 50 mg alternating with Placebo

Mavrilimumab 100 mg

Total, other (not including serious) adverse events

# participants affected / at risk

29/68 (42.65%)

36/70 (51.43%)

Blood and lymphatic system disorders

Leukocytosis¹,^†

# participants affected / at risk

0/68 (0.00%)

2/70 (2.86%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

0/68 (0.00%)

2/70 (2.86%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

1/68 (1.47%)

1/70 (1.43%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

1/68 (1.47%)

1/70 (1.43%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

2/68 (2.94%)

1/70 (1.43%)

# events

General disorders and administration site conditions

Influenza like illness¹,^†

# participants affected / at risk

0/68 (0.00%)

2/70 (2.86%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

2/68 (2.94%)

0/70 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

1/68 (1.47%)

1/70 (1.43%)

# events

Infections and infestations

Ear infection¹,^†

# participants affected / at risk

1/68 (1.47%)

1/70 (1.43%)

# events

Infections and infestations

Herpes simplex¹,^†

# participants affected / at risk

0/68 (0.00%)

2/70 (2.86%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

1/68 (1.47%)

1/70 (1.43%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

1/68 (1.47%)

4/70 (5.71%)

# events

Infections and infestations

Oral herpes¹,^†

# participants affected / at risk

0/68 (0.00%)

2/70 (2.86%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

2/68 (2.94%)

1/70 (1.43%)

# events

Infections and infestations

Rhinitis¹,^†

# participants affected / at risk

2/68 (2.94%)

1/70 (1.43%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

2/68 (2.94%)

3/70 (4.29%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

1/68 (1.47%)

2/70 (2.86%)

# events

Infections and infestations

Viral upper respiratory tract infection¹,^†

# participants affected / at risk

2/68 (2.94%)

3/70 (4.29%)

# events

Investigations

Alanine aminotransferase increased¹,^†

# participants affected / at risk

2/68 (2.94%)

0/70 (0.00%)

# events

Investigations

Hepatic enzyme increased¹,^†

# participants affected / at risk

2/68 (2.94%)

3/70 (4.29%)

# events

Metabolism and nutrition disorders

Dyslipidaemia¹,^†

# participants affected / at risk

2/68 (2.94%)

0/70 (0.00%)

# events

Metabolism and nutrition disorders

Hypercholesterolaemia¹,^†

# participants affected / at risk

2/68 (2.94%)

0/70 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

1/68 (1.47%)

1/70 (1.43%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

2/68 (2.94%)

2/70 (2.86%)

# events

Musculoskeletal and connective tissue disorders

Rheumatoid arthritis¹,^†

# participants affected / at risk

2/68 (2.94%)

1/70 (1.43%)

# events

Musculoskeletal and connective tissue disorders

Tendonitis¹,^†

# participants affected / at risk

2/68 (2.94%)

0/70 (0.00%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

2/68 (2.94%)

3/70 (4.29%)

# events

Nervous system disorders

Migraine¹,^†

# participants affected / at risk

0/68 (0.00%)

2/70 (2.86%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

0/68 (0.00%)

2/70 (2.86%)

# events

Skin and subcutaneous tissue disorders

Ecchymosis¹,^†

# participants affected / at risk

1/68 (1.47%)

1/70 (1.43%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

1/68 (1.47%)

3/70 (4.29%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 17.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule.

Results Point of Contact

Name/Title:	Marius Albulescu, Associate Medical Director
Organization:	MedImmune, LLC
Phone	301-398-0000
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

null MedImmune

clinicaltrialenquiries@medimmune.com

Investigators

Principal Investigator

Marius Albulescu

MedImmune Ltd.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site