The effect of adalimumab on immune markers in lesional psoriatic skin. - Adalimumab cell biology cohort study
- Conditions
- Plaque psoriasis
- Registration Number
- EUCTR2008-001952-32-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre - Department of Dermatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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: ß 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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To find out the dynamics of cell biological changes in lesional skin during treatment with adalimumab.;Secondary Objective: To find out whether adalimumab treatment results in <br>- a reduction of T cell subsets, <br>- normalization of proliferation and differentiation characteristics and<br>- a reduction of parameters for innate immunity<br><br>To find out the order in which the above mentioned parameters show an alteration.<br><br>To correlate the alteration of cell biological parameters with clinical improvement.;Primary end point(s): The PASI score at all visits and cell biological parameters in the punch biopsies for T cells, innate immunity and epidermal proliferation.
- Secondary Outcome Measures
Name Time Method