Status:
COMPLETED
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
656 Patients enrolled
Trial Details
Trial ID
NCT01232569
Start Date
March 1 2011
End Date
November 1 2013
Last Update
July 29 2015
Active Locations (141)
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1
Peoria, Arizona, United States, 85381
2
Scottsdale, Arizona, United States, 85258
3
Tucson, Arizona, United States, 85723
4
Tucson, Arizona, United States, 85724