A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02097745

Run by

Hoffmann-La Roche

People needed

341

Starts

2004-06-01

Expected to finish

2013-06-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients 18-80 years of age with active RA;
• patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
• eligible for re-treatment, based on clinical symptoms;
• patients of reproductive potential must be using reliable contraceptive methods.

You may not qualify if…

• patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
• current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
• development of any new contraindications to receiving MabThera;
• women who are pregnant or breast-feeding.

Where it is running

• Study site — Paradise Valley, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Fullerton, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Santa Maria, California, United States
• Study site — Danbury, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Shreverport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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