CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
rituximab [MabThera]drug
Likely dose
rituximab [MabThera] 1 gfrom 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/NCT02079532
NCT02079532Phase 3Completed
CompareCT.gov

An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent

Hoffmann-La Roche·interventional·Posted Mar 5, 2014·Updated Jul 29, 2016

In Brief

A Phase 3 clinical trial evaluating rituximab [MabThera] for Rheumatoid Arthritis. Completed, enrolled 302 participants across 69 sites.

Detailed Summary

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. 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
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 5, 2014
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 12.3 years ago

Interventions

rituximab [MabThera]drug

1 g was given by intravenous infusion on Days 1 and 15