A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methotrexate; methotrexate; placebo; tocilizumab [RoActemra/Actemra]
Intervention description: orally, Week 1 - 16; orally, Week 17-28; methotrexate placebo orally, Week 17-28; 8 mg/kg iv every 4 weeks, 28 weeks
Intervention MeSH terms: Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of
      RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra
      monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate.
      All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus
      oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be
      randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either
      methotrexate or placebo. Anticipated time on study treatment is 28 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline

          -  Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at
             least 15 mg/week for at least 6 weeks prior to treatment (Day 1)

          -  Body weight < 150 kg

          -  Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to
             baseline; maximum dose 10 mg/day

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months after baseline

          -  Rheumatic autoimmune disease other than RA

          -  Functional class IV as defined by the American College of Rheumatology (ACR)
             Classification of Functional Status in Rheumatoid Arthritis

          -  Prior history of or current inflammatory joint disease other than RA

          -  Treatment with a biologic agent at any time prior to baseline

          -  Treatment with traditional DMARDs other than methotrexate within 1 month (for
             leflunomide 3 months) prior to baseline

          -  Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

          -  Previous treatment with RoActemra/Actemra

          -  History of severe allergic or anaphylactic reactions to human, humanized, or murine
             monoclonal antibodies

          -  Known active current or history of recurrent infection

          -  History of or currently active primary or secondary immunodeficiency

          -  Active tuberculosis requiring treatment within the previous 3 years

          -  Positive for HIV infection