A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab SC; tocilizumab IV; placebo to tocilizumab SC; placebo to tocilizumab IV; Disease-modifying antirheumatic drugs (DMARDs)
Intervention description: Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.; Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.; Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.; Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.; stable dose as prescribed
Intervention MeSH terms: Antirheumatic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1262.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, parallel group study compares the efficacy and safety of
      subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with
      moderate to severe active rheumatoid arthritis. Participants were randomized to receive
      either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv
      every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24.
      The double-blind period was followed by a 72-week open-label treatment with some switching of
      sc and iv administration. No placebo was administered in the open-label phase. Participants
      continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout
      the study. Anticipated time on study treatment was 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, ≥ 18 years of age

          -  Rheumatoid arthritis of ≥ 6 months duration, according to American College of
             Rheumatology (ACR) criteria

          -  Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint
             count) at screening and baseline

          -  Inadequate response to current DMARD therapy

          -  Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline

          -  Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum
             recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline

        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 RA

          -  Functional class IV (ACR classification)

          -  Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis
             (JRA) and/or RA before the age of 16

          -  Prior history of or current inflammatory joint disease other than RA

          -  Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

          -  Previous treatment with tocilizumab

          -  Active current or history of recurrent infection