Evaluation of effectiveness of two dosing regimens of fostamatinib compared to placebo in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had inadequate response to single TNF-alpha antagonist - OSKIRA - 3
Study identifier:D4300C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-020745-27
CTIS identifier:N/A
Study Complete
Official Title
(OSKIRA-3): 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 Inadequate Response to a TNF-alpha antagonist
Medical condition
Rheumatoid Arthritis
Phase
Phase 3
Healthy volunteers
No
Study drug
fostamatinib, placebo
Sex
All
Actual Enrollment
638
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Feb 2013
Study Completion Date: 01 Feb 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
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No locations available
| 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 Placebo twice daily |
Contacts
Investigators
Principal Investigator
Neil MacKillop
AstraZeneca
