At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 520 enrolled
Drug / intervention
MabThera/Rituxan +2 moredrug
Likely dose
Not stated in 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, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies
In Brief
A Phase 3 clinical trial evaluating MabThera/Rituxan, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 520 participants across 115 sites in 11 countries.
Detailed Summary
This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, United Kingdom, United States
CollaboratorsBiogen
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2003
Primary CompletionJan 2005
First PostedMay 2007
Study CompletionJul 2012
TodayJul 2026
First PostedMay 2, 2007
Enrollment StartMay 1, 2003
Primary CompletionJan 1, 2005
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.2 years ago
Interventions
MabThera/Rituxandrug
1
Methotrexatedrug
2
Placeboother
3