NL-OMON32160尚未招募4 期
The effect of adalimumab on immune markers in lesional psoriatic skin. - Adalimumab cell biology cohort study
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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.
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: 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.
研究者
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