A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

Key facts

Study ID

NCT01232569

Run by

Hoffmann-La Roche

People needed

656

Starts

2011-03-01

Expected to finish

2013-11-01

Last updated by the study team

2015-07-29

Who can join

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

You may qualify if…

• Adult patients, ≥ years of age.
• Moderate to severe rheumatoid arthritis of ≥ 6 months duration.
• Receiving treatment on an outpatient basis.
• Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start.
• On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start.

You may not qualify if…

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
• Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed.
• Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
• Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years.
• Prior history of or current inflammatory joint disease other than rheumatoid arthritis.
• History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations.
• Other inclusion and exclusion criteria applied to the study.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fullerton, California, United States
• Study site — San Diego, California, United States
• Study site — San Leandro, California, United States
• Study site — West Hills, California, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Gainesville, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Meridan, Idaho, United States
• Study site — Springfield, Illinois, United States
• Study site — Vernon Hills, Illinois, United States
• Study site — Crofton, Maryland, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Wheaton, Maryland, United States
• Study site — Flowood, Mississippi, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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