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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT00235820

Run by

Abbott

People needed

271

Starts

2005-07-01

Last updated by the study team

2008-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Global Medical Information-Abbott — Abbott Park, Illinois, United States

Full record on ClinicalTrials.gov

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