A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00106522

Run by

Hoffmann-La Roche

People needed

499

Starts

2005-05-01

Expected to finish

2007-11-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
• inadequate response to current anti-rheumatic therapies, including MTX;
• inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
• on stable MTX for at least 8 weeks before entering study;
• patients of reproductive potential must be using reliable methods of contraception.

You may not qualify if…

• major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
• women who are pregnant or breast-feeding.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Fullerton, California, United States
• Study site — Long Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Desert, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Maria, California, United States
• Study site — Torrance, 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 — Palm Habor, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tavares, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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