Evaluation of effectiveness of two dosing regimens of fostamatinib compared to placebo in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. - OSKIRA - 1
Study identifier:D4300C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-020743-12
CTIS identifier:N/A
Study Complete
Official Title
(OSKIRA-1): 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 Methotrexate
Medical condition
Rheumatoid Arthritis
Phase
Phase 3
Healthy volunteers
No
Study drug
fostamatinib, placebo, fostamatinib
Sex
All
Actual Enrollment
1475
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Nov 2012
Study Completion Date: 01 Nov 2012
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, fostamatinib Placebo for 24 weeks followed by fostamatinib 100 mg twice daily |
Contacts
Investigators
Principal Investigator
Neil MacKillop
AstraZeneca
