Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After Adalimumab Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- changes in absolute numbers, density of immunocompetent cells and inflammatory cytokines expression pattern in psoriasic lesions vs normal skin of the same patient, pre and post-TNF alfa inhibitors treatment.
研究概览
简要总结
The efficacy of TNF alfa inhibitors in the treatment of psoriasis has been documented in many studies.
Their effect on dendritic cells has been scarcely studied. TNF- α has a central role in dendritic cell biology, both for their maturity and mobilization of peripheral tissues to secondary lymphoid organs.
The primary objectives of this study are:
- To document absolute number, density of immune infiltrate and dendritic cells and inflammatory cytokines expression pattern (particularly IFN α and IL-32) in psoriasic lesions vs normal skin of the same patient
- To describe changes in such cell numbers and expression patterns upon 16 weeks treatment with TNF alfa inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects > 18 years of age, affected by moderate to severe psoriasis
- •Subject has had clinical diagnosis of psoriasis for at least 12 months, stable plaque psoriasis for at least 2 months before screening (subjects with concurrent psoriatic arthritis may be enrolled).
- •Subject is naıve to TNF-antagonist therapy and efalizumab.
- •Subjects are considered eligible according to the following tuberculosis screening criteria:
- •Have no history of latent or active TB prior to screening;
- •Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
- •Within 1 month prior to the first administration of study medication, have negative diagnostic tuberculin skin test.
- •Normal chest X-ray within 3 months prior to screening with no evidence of malignancy, infection, current or old TB.
- •Subjects' screening and baseline clinical data must be within the normal limit, including the results of medical history, physical examination and laboratory evaluation (complete blood count, serum values for liver enzymes, bilirubin, glucose, albumin, creatinine and urine analysis).
- •Willing and able to comply with the protocol requirements for the duration of the study.
- •Women of childbearing potential must be using adequate birth control measure throughout the study and for 150 days (5 months) after study completion.
排除标准
- •Pregnant or breast-feeding women, or women who are planning pregnancy.
- •Patients not suitable for TNF alfa inhibitors therapy
研究组 & 干预措施
TNF alfa inhibitors
Male and female adult patients with a diagnosis of moderate to severe psoriasis (when PASI score is > 10 and BSA is > 10%). The overall study enrolment plan is 20 patients. Patients will be screened before the beginning of clinical trial by blood sample in order to exclude major contraindications to use of anti TNF α drugs.
干预措施: Adalimumab, etanercept, infliximab (Drug)
结局指标
主要结局
changes in absolute numbers, density of immunocompetent cells and inflammatory cytokines expression pattern in psoriasic lesions vs normal skin of the same patient, pre and post-TNF alfa inhibitors treatment.
时间窗: 12 months
* To document absolute number, density of immune infiltrate and dendritic cells and inflammatory cytokines expression pattern (particularly IFN α and IL-32) in psoriasic lesions vs normal skin of the same patient * To describe changes in such cell numbers and expression patterns upon 16 weeks treatment with biologics.
次要结局
未报告次要终点