NCT00687401已完成3 期
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 to Standard or Biologic Therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 215
- 主要终点
- Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score
研究概览
简要总结
Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=18 to 75 years of age, of either gender, and of any race.
- •Psoriasis covering at least 10% of total body surface area (BSA) and PASI >=12 at Screening and Baseline.
- •Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening.
- •Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab).
- •Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules.
- •Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.
- •Screening and Baseline tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within protocol-specified parameters.
- •Free of significant disease that could interfere with study evaluations.
- •Willing to give written informed consent and able to adhere to protocol visits and procedures.
- •Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication.
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
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 basal cell carcinoma [BCC]).
- •Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks.
- •Current drug-induced psoriasis.
- •Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab.
- •Previously treated with infliximab.
- •Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects.
- •History of chronic or recurrent infectious disease.
- •Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening.
- •Have or have had an opportunistic infection within 6 months prior to Screening.
结局指标
主要结局
Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score
时间窗: 10 weeks
PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
次要结局
未报告次要终点
研究者
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