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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2011
End Date:November 2013

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A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
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