A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab 162 mg; Placebo
Intervention description: Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.; Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 656.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 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.
    

Eligibility criteria:

        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.