Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00235820
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00235820
Study Brief:
Protocol Section:
NCT00235820