Adalimumab in Adult Japanese Subjects With Psoriasis

Sponsor
Abbott
Study ID
NCT00647400
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    Adalimumab 40 mg every other week, subcutaneous
  • adalimumab — BIOLOGICAL
    Adalimumab 80 mg every other week, subcutaneous

Study Details

To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis

Key Dates

Start date
Apr 30, 2006
Status verified
Apr 2011
Primary completion
Sep 30, 2007
Completion
Apr 30, 2010

Study Design

Enrollment
147 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab 40 mg every other week
  • Experimental: Adalimumab 80 mg every other week

Primary Outcome Measure

Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ]

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