At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 511 enrolled
Drug / intervention
Folate +4 moredrug
Likely dose
Folate 5 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 Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Folate, Methotrexate, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 511 participants.
Detailed Summary
This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
CollaboratorsHoffmann-La Roche
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedMar 2006
Primary CompletionJun 2008
Study CompletionJul 2013
TodayJul 2026
First PostedMar 6, 2006
Enrollment StartOct 1, 2005
Primary CompletionJun 1, 2008
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.3 years ago
Interventions
Folatedrug
A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.
Methotrexatedrug
A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.
Methylprednisolonedrug
Intravenous infusion
Placebodrug
Placebo to rituximab intravenous infusion
Rituximabdrug
Intravenous infusion