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 — DRUG40 mg every other week following an 80 mg dose
- MTX — DRUGMTX 7.5 to 25 mg once weekly
- placebo adalimumab, placebo MTX — DRUGplacebo 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Global Medical Information-Abbott | Abbott Park | Illinois | 60064 | - |
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