A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00109408

Run by

Hoffmann-La Roche

People needed

673

Starts

2005-07-01

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…

• adult patients at least 18 years of age with active RA for at least 3 months;
• 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 major surgery within 6 months after entering study;
• treatment with methotrexate (MTX) within 6 months of entering study;
• patients who have stopped previous MTX treatment due to toxicity or lack of response;
• women who are pregnant or breast-feeding.

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Huntington Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Springs, California, United States
• Study site — Sacramento, California, United States
• Study site — San Leandro, California, United States
• Study site — Santa Maria, California, United States
• Study site — Jupiter, Florida, United States
• Study site — Palm Habor, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Morton Grove, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Cedar Rapids, Iowa, United States
• Study site — Des Moines, Iowa, United States
• Study site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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