At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 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-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
In Brief
A Phase 3 clinical trial evaluating fostamatinib and placebo for Rheumatoid Arthritis. Completed, enrolled 323 participants across 135 sites in 16 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 and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Mexico, Portugal, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionFeb 2013
TodayJul 2026
First PostedSep 9, 2010
Enrollment StartSep 1, 2010
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.8 years ago
Interventions
fostamatinibdrug
fostamatinib 100 mg twice daily
fostamatinibdrug
fostamatinib 100 mg twice daily/150 mg once daily
placebodrug
Placebo twice daily