Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Part of paid clinical trials in Abbott Park, Illinois.

Sponsor
Abbott
Study ID
NCT00235820
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — DRUG
    40 mg every other week following an 80 mg dose
  • MTX — DRUG
    MTX 7.5 to 25 mg once weekly
  • placebo adalimumab, placebo MTX — DRUG
    placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)

Study Details

Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Key Dates

Start date
Jul 31, 2005
Status verified
Jun 2008
Primary completion
May 31, 2006

Study Design

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

Arms

  • Active Comparator: A
  • Active Comparator: B
  • Placebo Comparator: C

Primary Outcome Measure

Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. [ Time Frame: Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Global Medical Information-AbbottAbbott ParkIllinois60064-

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