CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 465 enrolled
Drug / intervention
Rituximab +3 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/NCT02093026
NCT02093026Phase 2Completed
CompareCT.gov

An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis

Hoffmann-La Roche·interventional·Posted Mar 20, 2014·Updated Mar 13, 2017

In Brief

A Phase 2 clinical trial evaluating Rituximab, Methotrexate, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 465 participants across 92 sites in 16 countries.

Detailed Summary

This study will assess the long-term safety and efficacy of repeat treatment courses of rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug (DMARD) inadequate responder population of participants who were previously randomized into studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple re-treatments until the protocol-defined end-of-treatment date (31 December 2011). Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will provide at least 7 years follow-up data on all participants initially randomized into WA16291 or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this open label extension study from their respective feeder studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Belgium, Brazil, Canada, Czechia, Finland, Germany, Israel, Italy, Mexico, New Zealand, Poland, Spain, Sweden, United Kingdom, United States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 20, 2014
Enrollment StartAug 1, 2002
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 12.3 years ago

Interventions

Rituximabdrug

Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment.

Methotrexatedrug

Participants will receive methotrexate 10-25 mg/week orally or parenterally.

Methylprednisolonedrug

Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion.

Folic Aciddrug

Participants will receive folic acid \>= 5 mg/week or equivalent.