Status:
COMPLETED
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Lead Sponsor:
Abbott
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT00235820
Start Date
July 1 2005
Last Update
July 17 2008
Active Locations (1)
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1
Global Medical Information-Abbott
Abbott Park, Illinois, United States, 60064