Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

Sponsor
Abbott
Study ID
NCT01114880
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week
  • placebo — OTHER
    Prefilled syringe, matching placebo administered subcutaneously every other week

Study Details

Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Key Dates

Start date
Jan 31, 2010
Status verified
Nov 2011
Primary completion
Sep 30, 2010
Completion
Feb 28, 2011

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.
  • Experimental: Adalimumab
    Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24.

Primary Outcome Measure

Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria [ Time Frame: Week 12 ]

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