Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

Sponsor
Centocor, Inc.
Study ID
NCT01248793
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20
  • Golimumab — DRUG
    Golimumab 50 mg SC injection every 4 weeks for 48 weeks
  • Golimumab (placebo group) — DRUG
    Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48

Study Details

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis

Key Dates

Start date
Oct 31, 2010
Status verified
Mar 2013
Primary completion
May 31, 2011
Completion
Mar 31, 2012

Study Design

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

Arms

  • Experimental: Placebo
  • Experimental: Golimumab

Primary Outcome Measure

Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 [ Time Frame: Week 14 ]

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