A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; adalimumab; placebo to tocilizumab; placebo to adalimumab; methotrexate; folate
Intervention description: Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks.; Adalimumab 40 mg SC every 2 weeks.; Placebo to tocilizumab IV every 4 weeks for 24 weeks.; Placebo to adalimumab SC every 2 weeks for 24 weeks.; Methotrexate 10-25 mg weekly.; Folate at least 5 mg weekly.
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, parallel-group study will assess the efficacy and safety of
      RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate
      (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already
      treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8
      mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks.
      All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly).
      The anticipated time on study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Rheumatoid arthritis of >/= 6 months duration (according to American College of
             Rheumatology (ACR) criteria)(according to ACR criteria)

          -  Inadequate response due to inefficacy of treatment (for at least 3 months) with only
             one approved Tumor Necrosis Factor (TNF)-agent other than adalimumab Depending on the
             TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before
             randomization to the study

          -  On methotrexate treatment for >/=12 weeks immediately prior to baseline, with stable
             dose (10-25 mg/week) for the last 8 weeks

          -  Disease Activity Score (DAS28) >3.2 at baseline

          -  Oral corticosteroids (</=10 mg/day prednisone or equivalent) and non-steroidal
             anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for >/=6
             weeks prior to baseline.

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             surgery within 6 months following randomization

          -  Rheumatic autoimmune disease other than rheumatoid arthritis

          -  Prior history of or current inflammatory joint disease other than rheumatoid arthritis

          -  Functional class IV (ACR criteria)

          -  History of severe allergic reaction to human, humanized or murine monoclonal
             antibodies

          -  Known active current or history of recurrent infection (including tuberculosis)

          -  Primary or secondary immunodeficiency (history of or currently active)

          -  Body weight >150 kg

          -  Previous treatment with any cell-depleting therapies

          -  Previous treatment with tocilizumab

          -  Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline.