At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 923 enrolled
Drug / intervention
fostamatinib +2 moredrug
Likely dose
fostamatinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
(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
In Brief
A Phase 3 clinical trial evaluating fostamatinib and placebo, fostamatinib for Rheumatoid Arthritis. Completed, enrolled 923 participants across 127 sites in 17 countries.
Detailed Summary
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Chile, Estonia, France, Hungary, India, Mexico, Peru, Poland, Slovakia, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionNov 2012
TodayJul 2026
First PostedSep 9, 2010
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.8 years ago
Interventions
fostamatinibdrug
fostamatinib 100 mg twice daily
fostamatinibdrug
fostamatinib 100 mg twice daily/150 mg once daily
placebo, fostamatinibdrug
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily