Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01646073
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    adalimumab eow
  • placebo — BIOLOGICAL
    placebo

Study Details

A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

Key Dates

Start date
Aug 31, 2012
Status verified
Jan 2015
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

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

Arms

  • Experimental: Adalimumab
    Adalimumab 40 mg every other week (eow)
  • Placebo Comparator: Placebo
    placebo

Primary Outcome Measure

Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 [ Time Frame: Week 12 ]

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