EUCTR2005-004465-41-IT进行中（未招募）不适用
A multi-center, open-label trial evaluating the Efficacy, Safety and the Impact on Quality of Life of Infliximab Therapy in patients with moderate to severe psoriasis not responding and/or intolerant to systemic standard or biologic therapy - ESAQUALITY. - ESAQUALITY
SCHERING-PLOUGH0 个研究点开始时间: 2006年3月14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
- •- Patients must be <=18 to 75 years of age, of eigher gender and of any race. - Patients must have psoriasis covering at least 10% of total BSA and PASI score of 12 or greater at screening and baseline. - Patients must have had a diagnosis of moderate to severe psoriasis at least 24 months prior to screening (patients with concurrent psoriatic arthritis may be enrolled). - Patients eligible to Infliximab treatment who have failed at least on of the following psoriasis treatments: Corticosteroids, MTX, systemic retinoids, Cyclosporine, PUVA, UVB phototherapy and/or biologics (etanercept or efalizumab). - Patients are considered eligible according to the tubercolosis (TB) eligibility assessment, screening and early detection of reactivation rules (specific section in the protocol). - Patients must have had a chest X-ray (posterior-anterior and lateral) within 3 months prior the screening with no evidence of malignancy, infections, or fibrosis. - Patients' screening and baseline test (CBC, blood chemistry, and urianalysis)must be within the following parameters: Hemoglobin: <= 10 g/dL White blood cells: <=3.5x109L Neutrophils: <=1.5x109L Platelets: <=100x109L Serum creatinine: >1.5 mg/dL AST, ALT, alkaline phosphatase and gamma-glutamyltransferase >= x upper normal limit of normal range for the laboratory conducting the test. Patients must be free of any clinically significant disease (other than psoriasis or psoriatic arthritis) that could interfere with the study evaluation. Patients must be willing to give written informed consent and be able to adhere to protocol visit and procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •- Standard concomitant psoriasis therapies. - Active or latent TB. - History of chronic infectious disease, opportunistic infection or serious infection within 2 months of enrollment. - History of lymphoproliferative disease. - Malignancy in past 5 years (except treated BCC). - Treatment with TNF antagonist within previous 12 weeks or other experimental drugs within previous 4 weeks. - Patients who have current-drug induced psoriasis. - Female patients who are pregnant or nursing. Patients previously treated with Infliximab. - Patients who have a concomitant diagnosis of CHF.
研究者
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