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

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

271

Study ID:

NCT00235820

Recruitment Status:

Completed

Sponsor:

Abbott

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There is 1 Location for this study

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Global Medical Information-Abbott
Abbott Park Illinois, 60064, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

271

Study ID:

NCT00235820

Recruitment Status:

Completed

Sponsor:


Abbott

How clear is this clinincal trial information?

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