At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 755 enrolled
Drug / intervention
folate +4 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, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating folate, methotrexate, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 755 participants.
Detailed Summary
This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
CollaboratorsHoffmann-La Roche
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedMar 2006
Primary CompletionSep 2008
Study CompletionJul 2013
TodayJul 2026
First PostedMar 6, 2006
Enrollment StartJan 1, 2006
Primary CompletionSep 1, 2008
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.3 years ago
Interventions
folatedrug
Intravenous repeating dose
methotrexatedrug
Oral or parenteral repeating dose
methylprednisolonedrug
Intravenous repeating dose
placebodrug
Intravenous repeating dose
rituximabdrug
Intravenous repeating dose