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Evaluation of effectiveness of two dosing regimens of fostamatinib compared to placebo in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not responding. - OSKIRA - 2
Study identifier:D4300C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-020744-35
CTIS identifier:N/A
Study Complete
Official Title
(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs
Medical condition
Rheumatoid Arthritis
Phase
Phase 3
Healthy volunteers
No
Study drug
fostamatinib, placebo, fostamatinib
Sex
All
Actual Enrollment
1632
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 Mar 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Hamilton, ON, Canada
Location
Research Site
Quebec, QC, Canada
Location
Research Site
Toronto, ON, Canada
Location
Research Site
Mississauga, ON, Canada
Location
Research Site
Ottawa, ON, Canada
Location
Research Site
Winnipeg, MB, Canada
Location
Research Site
Bowmanville, ON, Canada
Location
Research Site
Edmonton, AB, Canada
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dosing Regimen A Oral Treatment | Drug: fostamatinib fostamatinib 100 mg twice daily |
| Experimental: Dosing Regimen B Oral Treatment | Drug: fostamatinib fostamatinib 100 mg twice daily/ 150 mg once daily |
| Placebo Comparator: Dosing Regimen C Oral Treatment | Drug: placebo, fostamatinib Placebo for 24 weeks followed by fostamatinib 100 mg twice daily. |
Contacts
Investigators
Principal Investigator
Neil MacKillop
AstraZeneca
