The effect of adalimumab on immune markers in lesional psoriatic skin.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Subjects 18 years of age or older who have moderate to severe plaque psoriasis, as defined by PASI score >= 10 or PASI score >= 8 AND Skindex total score > 35 at the baseline (week 0) visit. Patients have failed, are intolerant or have contraindications to methotrexate, PUVA and cyclosporin.

Exclusion Criteria

- Known history of allergic reaction or significant 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 enrolment.
- Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Use of PUVA for at least 4 weeks prior to Baseline.
- Use of oral or injectable corticosteroids for at least 4 weeks prior to Baseline and during the study.
- Use of medication which may aggravate psoriasis: β blockers, antimalaria drugs, NSAID and lithium carbonate.
- Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
- Other active skin diseases or skin infections (bacterial, viral or fungal) that may interfere with evaluation of psoriasis.
- History of listeriosis, histoplasmosis, untreated TB, persistent chronic infections.
- Recent active infections requiring hospitalization or treatment with intravenous (IV) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit.
- Immune deficiency, history of HIV or is immunocompromised.
- Use of anti-retroviral therapy.
- Positive Hepatitis B or C (previous infection).
- History of neurologic symptoms suggestive of central nervous system demyelinating disease.
- Malignancies other than successfully treated non-metastatic cutaneous squamous cell of basal cell carcinoma, or cervical carcinoma in situ.
- Erythrodermic, generalized pustule, new onset guttate, or medication-related or exacerbated psoriasis vulgaris.
- Subject has a poorly controlled medical condition.
- Female subject who is pregnant or breast-feeding or has positive serum pregnancy test at screening or considering becoming pregnant during the study or within 5 months after the last dose of adalimumab.
- History of keloid formation following wounding.
- Investigator considers the subject unsuitable for adalimumab for any reason.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The PASI score at all visits.<br /><br>Cell biological parameters in the punch biopsies for T cells, innate immunity<br /><br>and epidermal proliferation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>

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