At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 457 enrolled
Drug / intervention
Fostamatinib disodium (R935788) +2 moredrug
Likely dose
Fostamatinib disodium (R935788) 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.
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
In Brief
A Phase 2 clinical trial evaluating Fostamatinib disodium (R935788) and Placebo for Rheumatoid Arthritis. Completed, enrolled 457 participants across 65 sites in 6 countries.
Detailed Summary
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Colombia, Mexico, Poland, Romania, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartMay 2008
Primary CompletionJun 2009
TodayJul 2026
First PostedApr 24, 2008
Enrollment StartMay 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.2 years ago
Interventions
Fostamatinib disodium (R935788)drug
100 mg tablet, orally, twice-a-day
Fostamatinib disodium (R935788)drug
150 mg tablet, orally, once a day
Placebodrug
Placebo, orally, either once a day, or twice a day