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

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00106574

Run by

Hoffmann-La Roche

People needed

1220

Starts

2005-04-01

Expected to finish

2007-12-01

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…

• 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 1 or more traditional DMARDs;
• stable DMARD therapy 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 entering study, or planned surgery within 6 months after entering study;
• patients who have previously failed treatment with an anti-tumor necrosis factor agent;
• women who are pregnant or breast-feeding.

Where it is running

• Study site — Paradise Valley, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Desert, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Jose, California, United States
• Study site — Upland, California, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Delray Beach, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Palm Habor, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Vernon Hills, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Bowling Green, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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