Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Sponsor
Centocor, Inc.
Study ID
NCT01248780
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Golimumab — DRUG
    50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks
  • Placebo — DRUG
    Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48.
  • Methotrexate (MTX) — DRUG
    A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.

Study Details

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.

Key Dates

Start date
Sep 30, 2010
Status verified
Aug 2013
Primary completion
Oct 31, 2011
Completion
Jul 31, 2012

Study Design

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

Arms

  • Experimental: Golimumab + methotrexate (MTX)
    Participants will receive golimumab 50 mg as subcutaneous (SC) (under the skin) injections administered every 4 weeks for up to 48 weeks. In addition, participants will receive a stable dose of MTX.
  • Experimental: Placebo + methotrexate (MTX)
    Participants will be administered Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48. In addition, participants will receive a stable dose of MTX.

Primary Outcome Measure

American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 [ Time Frame: Week 14 ]

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