A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

Sponsor
Hoffmann-La Roche
Study ID
NCT01587989
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • methotrexate — DRUG
    15-25 mg orally weekly, Weeks 1-12
  • methotrexate — DRUG
    15-25 mg orally weekly, Weeks 13-24
  • placebo — DRUG
    methotrexate placebo orally weekly, Weeks 13-24
  • tocilizumab [RoActemra/Actemra] — DRUG
    8 mg/kg iv every 4 weeks, 24 weeks

Study Details

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.

Key Dates

Start date
Feb 29, 2012
Status verified
Jun 2015
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

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

Arms

  • Active Comparator: A Methotrexate
  • Experimental: B Methotrexate Placebo

Primary Outcome Measure

Change From Week 12 (Randomization) to Week 24 in DAS28 [ Time Frame: Weeks 12 and 24 ]

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