Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02093026

Run by

Hoffmann-La Roche

People needed

465

Starts

2002-08-01

Expected to finish

2012-12-01

Last updated by the study team

2017-03-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• participants with active RA
• completed 24 weeks of treatment in WA16291 or WA17043
• eligible for re-treatment, based on clinical symptoms (Disease Activity Score in 28 joints >=2.6)
• females of childbearing potential using reliable contraception

You may not qualify if…

• participants who participated in rituximab studies WA16291 or WA17043 but withdrew into the safety follow-up phases of these trials
• previous rituximab non-responders
• current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-tumor necrosis factor alfa, anti-interleukin-1, or other biologic therapies
• participants with known active infection of any kind
• evidence of any new or uncontrolled concomitant disease or development of any new contraindications which would preclude repeat treatment with rituximab
• history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• female participants who are pregnant or breastfeeding

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Boca Raton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Largo, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Boise, 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 — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Great Neck, New York, United States
• Study site — Plainview, New York, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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