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

Sponsor
Hoffmann-La Roche
Study ID
NCT01399697
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • methotrexate — DRUG
    orally, Week 1 - 16
  • methotrexate — DRUG
    orally, Week 17-28
  • placebo — DRUG
    methotrexate placebo orally, Week 17-28
  • tocilizumab [RoActemra/Actemra] — DRUG
    8 mg/kg iv every 4 weeks, 28 weeks

Study Details

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.

Key Dates

Start date
Sep 30, 2011
Status verified
May 2015
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
261 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Active Comparator: B

Primary Outcome Measure

Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28 [ Time Frame: Baseline, Week 16, and Week 28 ]

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