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

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.

We found this trial at

sites

Clinical Trial Facility in Crofton Maryland

Crofton, Maryland 21114

from

Crofton, MD