Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

Sponsor
Abbott
Study ID
NCT00195819
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab (D2E7) — BIOLOGICAL
    Adalimumab 40 mg every other week (eow)
  • placebo — BIOLOGICAL
    Placebo every other week (eow)

Study Details

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis

Key Dates

Start date
Dec 31, 2003
Status verified
Jun 2011
Primary completion
Oct 31, 2004
Completion
Jun 30, 2009

Study Design

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

Arms

  • Experimental: Adalimumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 [ Time Frame: Week 12 ]

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