A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methotrexate; methotrexate; placebo; tocilizumab [RoActemra/Actemra]
Intervention description: 15-25 mg orally weekly, Weeks 1-12; 15-25 mg orally weekly, Weeks 13-24; methotrexate placebo orally weekly, Weeks 13-24; 8 mg/kg iv every 4 weeks, 24 weeks
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter study with a randomized, double-blind, parallel-group phase will evaluate
      the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate
      versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis,
      with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg
      intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients
      with a good/moderate EULAR response will then be randomized to receive either
      RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12
      weeks. Anticipated time on study treatment is 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Rheumatoid arthritis of >/= 1 year duration

          -  Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)

          -  On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to
             25 mg/week for at least 6 weeks prior to Day 1

          -  Body weight </= 150 kg

          -  Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25
             out of 28 days prior to baseline

        Exclusion Criteria:

          -  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 rheumatoid arthritis

          -  Functional class IV American College of Rheumatology (ACR) Classification

          -  Prior history of or current inflammatory joint disease other than rheumatoid arthritis

          -  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 tocilizumab

          -  Pregnant or lactating women

          -  Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease
             where flares are commonly treated with oral or parenteral corticosteroids

          -  Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
             or other infections

          -  History of or currently active primary or secondary immunodeficiency

          -  Evidence of active malignant disease, malignancies diagnosed within the previous 5
             years

          -  Active tuberculosis requiring treatment within the previous 3 years

          -  Positive for HIV infection