EUCTR2008-001952-32-NL进行中（未招募）不适用
The effect of adalimumab on immune markers in lesional psoriatic skin. - Adalimumab cell biology cohort study
Radboud University Nijmegen Medical Centre - Department of Dermatology0 个研究点开始时间: 2008年10月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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