Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Phase 3
Completed
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT00235820
- Lead Sponsor
- Abbott
- Brief Summary
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 271
Inclusion Criteria
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
- Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
- Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
- Male subjects must hve been vasectomized or practicing birth control.
Exclusion Criteria
- Previous systemic anti-TNF therapy.
- Prior use of MTX.
- Known hypersensitivity to the constituents of adalimumab.
- Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
- Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
- Use of PUVA for at least 4 weeks prior to Baseline.
- Use of oral or injectable corticosteroids during the study.
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who is pregnant or breast feeding or considering becoming pregnant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C placebo adalimumab, placebo MTX - A adalimumab - B MTX -
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. Week 16 Safety parameters Every Study Visit
- Secondary Outcome Measures
Name Time Method Physician Global Assessment Baseline - Week 16 PASI 50/90/100 Baseline - Week 16 DLQI Baseline - Week 16
Trial Locations
- Locations (1)
Global Medical Information-Abbott
🇺🇸Abbott Park, Illinois, United States