Psoriasis Clinical Trial
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Summary
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Eligibility Criteria
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.
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There is 1 Location for this study
Abbott Park Illinois, 60064, United States
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