A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis

Inclusion Criteria

• Subject has a clinical diagnosis of psoriasis for at least 6 months prior to the Screening, as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
• Subject must have stable plaque psoriasis for at least 2 months prior to the Screening, as determined by subject interview of his/her medical history
• Subject has moderate to severely active plaque psoriasis at Baseline defined as: BSA (Body Surface Area) > 10% and a Psoriasis Area and Severity Index (PASI) > 12
• Subject has active psoriasis despite treatment with topical agents
• Subject has failed to respond to, is intolerant to or unable to access phototherapy
• Subject has failed to respond to, is intolerant to or has contraindication for at least two of the following therapies:
• CyA (Cyclosporine A)
• MTX (Methotrexate)
• Oral retinoid
• If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
• Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
• Contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration
• A vasectomized partner
• Total abstinence from sexual intercourse
• If female and of childbearing potential, the result of a serum pregnancy test performed at Screening is negative
• Able and willing to self-administer sc injections or has available qualified person(s) to administer sc injections
• Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria

• Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with the evaluation of psoriasis or compromise the subject's safety
• Subject has erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis as the primary morphology of their psoriasis
• Subject has a history of an allergic reaction or significant sensitivity to constituents of adalimumab
• Investigational agents not mentioned must be discontinued at least 30 days or 5 half-lives prior to the Baseline visit (whichever is longer)
• Topical therapies:
• Subject started receiving a new topical therapy within the last four weeks prior to the Baseline visit for areas other than the palms, soles of feet, axilla and groin.
• Dose(s) and regimen(s) of topical therapy(ies) that the subject is receiving at the Baseline visit, for areas other than the palms, soles of feet, axilla and groin, was (were) increased during the four weeks that preceded the Baseline visit.
• Subject is likely to require the initiation of a new topical therapy for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids during the first 16 weeks that will follow the Baseline visit. (During the first 16 weeks that will follow the Baseline visit, initiation of topical therapies are allowed for the palms, soles of feet, axilla and groin area only).
• Oral or injectable corticosteroids therapies:
• Subject started receiving oral or injectable doses of corticosteroids within the last four weeks prior to the Baseline visit.
• Dose(s) and regimen(s) of corticosteroids therapy(ies) that the subject is receiving at the Baseline visit, was (were) increased during the four weeks that preceded the Baseline visit.
• Subject is likely to require the initiation of oral or injectable dose of corticosteroids therapies for the treatment of psoriasis during the first 16 weeks that will follow the Baseline visit.
• Phototherapies
• Subject started being treated with UVB phototherapy, within the last four weeks prior to the Baseline visit.
• Regimen(s) of concomitant UVB photot