CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 378 enrolled
Drug / intervention
rituximab [MabThera/Rituxan] +2 moredrug
Likely dose
rituximab [MabThera/Rituxan] 500mgfrom 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.

Search/NCT00422383
NCT00422383Phase 3Completed
CompareCT.gov

A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

Hoffmann-La Roche·interventional·Posted Jan 17, 2007·Updated May 4, 2015

In Brief

A Phase 3 clinical trial evaluating rituximab [MabThera/Rituxan] for Rheumatoid Arthritis. Completed, enrolled 378 participants across 91 sites in 18 countries.

Detailed Summary

This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Belgium, Brazil, Canada, China, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, Slovakia, South Africa, Spain, Taiwan, Thailand, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartFeb 1, 2006
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 19.5 years ago

Interventions

rituximab [MabThera/Rituxan]drug

500mg iv in days 1 and 15, and 500mg iv on days 168 and 182

rituximab [MabThera/Rituxan]drug

500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182

rituximab [MabThera/Rituxan]drug

1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182