CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 341 enrolled
Drug / intervention
methotrexate +1 moredrug
Likely dose
methotrexate 25 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.

Search/NCT02097745
NCT02097745Phase 3Completed
CompareCT.gov

An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

Hoffmann-La Roche·interventional·Posted Mar 27, 2014·Updated Nov 3, 2016

In Brief

A Phase 3 clinical trial evaluating methotrexate and rituximab [MabThera/Rituxan] for Rheumatoid Arthritis. Completed, enrolled 341 participants across 97 sites in 11 countries.

Detailed Summary

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

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
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2014
Enrollment StartJun 1, 2004
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 12.3 years ago

Interventions

methotrexatedrug

a 10-25 mg stable dose given orally or parenterally throughout study

rituximab [MabThera/Rituxan]drug

1 g given by intravenous infusion on Days 1 and 15 of each treatment course