A long term study to assess the safety of fostamatinib in patients in Asia with Rheumatoid Arthritis - OSKIRA-Asia-1X

Study identifier:D4300C00029

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Medical condition

Rheumatoid Arthritis

Phase

Phase 2

Healthy volunteers

Study drug

Fostamatinib

Sex

All

Actual Enrollment

117

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Jul 2012

Primary Completion Date: 01 Jun 2013

Study Completion Date: 01 Jul 2013

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2014 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Hongkong, Hong Kong

Location

Research Site

Hong Kong, Hong Kong

Location

Research Site

Kitakyushu-shi, Japan

Location

Research Site

Fukuoka-shi, Japan

Location

Research Site

Omura-shi, Japan

Location

Research Site

Hamamatsu-shi, Japan

Location

Research Site

Sasebo-shi, Japan

Location

Research Site

Okayama-shi, Japan

Arms	Assigned Interventions
Experimental: Dosing regimen Open label Oral treatment 100mg once daily	Drug: Fostamatinib Fostamatinib 100mg once daily

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 115 patients were enrolled; all received at least 1 dose of investigational product. This was an open-label study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patients failed screening.

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Participant Flow: Overall Study

	FOSTA 100 MG QD PO
STARTED	115^[1]
Did not receive treatment	0
COMPLETED	109^[2]
NOT COMPLETED	6
Study-specific disc criteria	1
Lack of Efficacy	3
Adverse Event	2

[1]	Patients who received treatment
[2]	Number of patients on treatment when the study was stopped.

Baseline Characteristics

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

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Baseline Measures

	FOSTA 100 MG QD PO
Number of Participants [units: Participants]	115
Age Continuous [units: years] Mean ± Standard Deviation	53 ± 11.3
Gender, Male/Female [units: Participants]
Female	101
Male	14
Race/Ethnicity, Customized [units: Participants]
White	0
Black or African American	0
Asian	115
American Indian or Alaska Native	0
Indian or Pakistani	0
Native Hawaiian or other Pacific Islander	0

Outcome Measures

1. Primary Outcome Measure: Percentage of patients who had at least 1 adverse event in any category [ Time Frame: Entry in extension to study termination (variable duration; maximum 52 weeks) ]

Measure Type	Primary
Measure Name	Percentage of patients who had at least 1 adverse event in any category
Measure Description	AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event
Time Frame	Entry in extension to study termination (variable duration; maximum 52 weeks)
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 full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Measured Values

	FOSTA 100 MG QD PO
Number of Participants Analyzed [units:participants]	115
Percentage of patients who had at least 1 adverse event in any category [units: Percentage of patients]
Any AE	62.6
Any AE with outcome of death	0
Any SAE (including events with outcome of death)	3.5
Any AE leading to discontinuation of IP	2.6

No statistical analysis provided for Percentage of patients who had at least 1 adverse event in any category

2. Secondary Outcome Measure: Components of ACR response criteria over time [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end ]

Measure Type	Secondary
Measure Name	Components of ACR response criteria over time
Measure Description	ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily
Time Frame	Every 12 weeks for one year then every 24 weeks until study end
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.
Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Measured Values

	FOSTA 100 MG QD PO
Number of Participants Analyzed [units:participants]	0
Components of ACR response criteria over time [units: n/a] Mean (Standard Deviation)

No statistical analysis provided for Components of ACR response criteria over time

3. Secondary Outcome Measure: DAS28-CRP score over time [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end ]

Measure Type	Secondary
Measure Name	DAS28-CRP score over time
Measure Description	CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily
Time Frame	Every 12 weeks for one year then every 24 weeks until study end
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.
Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Measured Values

	FOSTA 100 MG QD PO
Number of Participants Analyzed [units:participants]	0
DAS28-CRP score over time [units: n/a] Mean (Standard Deviation)

No statistical analysis provided for DAS28-CRP score over time

4. Secondary Outcome Measure: HAQ-DI score over time [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end ]

Measure Type	Secondary
Measure Name	HAQ-DI score over time
Measure Description	HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily
Time Frame	Every 12 weeks for one year then every 24 weeks until study end
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.
Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Measured Values

	FOSTA 100 MG QD PO
Number of Participants Analyzed [units:participants]	0
HAQ-DI score over time [units: n/a] Mean (Standard Deviation)

No statistical analysis provided for HAQ-DI score over time

5. Secondary Outcome Measure: SF-36 score over time [ Time Frame: Every 12 weeks for one year then yearly until study end ]

Measure Type	Secondary
Measure Name	SF-36 score over time
Measure Description	n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey
Time Frame	Every 12 weeks for one year then yearly until study end
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.
Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Measured Values

	FOSTA 100 MG QD PO
Number of Participants Analyzed [units:participants]	0
SF-36 score over time [units: n/a] Mean (Standard Deviation)

No statistical analysis provided for SF-36 score over time

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Serious Adverse Events

FOSTA 100 MG QD PO

Total, serious adverse events

# participants affected / at risk

4/115 (3.48%)

GASTROINTESTINAL DISORDERS

PANCREATITIS ACUTE¹,^†

# participants affected / at risk

1/115 (0.87%)

# events

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

ROAD TRAFFIC ACCIDENT¹,^†

# participants affected / at risk

1/115 (0.87%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

OSTEONECROSIS¹,^†

# participants affected / at risk

1/115 (0.87%)

# events

NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)

SEBORRHOEIC KERATOSIS¹,^†

# participants affected / at risk

1/115 (0.87%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 16.0

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
FOSTA 100 MG QD PO	Fostamatinib 100 mg qd

Other Adverse Events

FOSTA 100 MG QD PO

Total, other (not including serious) adverse events

# participants affected / at risk

29/115 (25.22%)

BLOOD AND LYMPHATIC SYSTEM DISORDERS

NEUTROPENIA¹,^†

# participants affected / at risk

6/115 (5.22%)

# events

INFECTIONS AND INFESTATIONS

NASOPHARYNGITIS¹,^†

# participants affected / at risk

14/115 (12.17%)

# events

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

RHEUMATOID ARTHRITIS¹,^†

# participants affected / at risk

7/115 (6.09%)

# events

VASCULAR DISORDERS

HYPERTENSION¹,^†

# participants affected / at risk

7/115 (6.09%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 16.0

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:

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
Insufficient efficacy data was available for analysis due to sparse data collection and the early termination of the study.

Results Point of Contact

Name/Title:	Dave Goldstraw
Organization:	AstraZeneca Pharmaceuticals
Phone	+44 (0)1625 512415
E-mail:	[email protected]

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

ClinicalTrialTransparency@astrazeneca.com

Investigators

Principal Investigator

Neil - MacKillop

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

CSR Synopsis

Trial Results Summaries