A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

Completed · Phase 4 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

Key facts

Study ID

NCT01119859

Run by

Hoffmann-La Roche

People needed

326

Starts

2010-05-01

Expected to finish

2012-01-01

Last updated by the study team

2013-02-11

Who can join

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

You may qualify if…

• Adult patients, ≥ 18 years of age.
• Rheumatoid arthritis of > 6 months duration.
• Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
• All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
• Weight ≤ 150 kg.

You may not qualify if…

• Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
• History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
• Treatment with a biologic agent at any time prior to baseline.
• Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
• Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Springfield, Illinois, United States
• Study site — Cumberland, Maryland, United States
• Study site — Flowood, Mississippi, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Dover, New Hampshire, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Hickory, North Carolina, United States
• Study site — Dayton, Ohio, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Willow Grove, Pennsylvania, United States
• Study site — Wyomissing, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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