A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

Key facts

Study ID

NCT00810199

Run by

Hoffmann-La Roche

People needed

556

Starts

2009-03-01

Expected to finish

2013-01-01

Last updated by the study team

2014-07-18

Who can join

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

You may qualify if…

• adult patients, ≥ 18 years of age;
• moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) > 4.4);
• inadequate response to methotrexate;
• on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.

You may not qualify if…

• prior treatment with a biologic;
• Rheumatoid arthritis (RA) functional class IV;
• known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
• evidence of active malignant disease.

Where it is running

• Study site — Upland, California, United States
• Study site — Whittier, California, United States
• Study site — Aventura, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Orange Park, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Eagan, Minnesota, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Mayfield, Ohio, United States
• Study site — Middleburg Heights, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — West Reading, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Spokane, Washington, United States
• Study site — Belo Horizonte, Minas Gerais, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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