NCT00687362已完成2 期
A Multicenter, Multinational, Open Label Study on the Efficacy and Safety of Infliximab Monotherapy in Moderate-to-severe Chronic Plaque Psoriasis in Middle Eastern Population
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
研究概览
简要总结
Middle Eastern subjects with moderate-to-severe chronic plaque psoriasis will be administered infusions of infliximab (Remicade) at 5 mg/kg of body weight at Weeks 0, 2, 6, 14, and 22. The safety and efficacy of infliximab monotherapy will be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older, either gender, and any race.
- •Psoriasis affecting >=5% of body surface, PASI score >=10 (maximum score 72).
- •History of plaque psoriasis for >6 months.
- •Informed written consent.
- •Refractory to other anti-psoriasis agents (topical corticosteroids, phototherapy UVa [PUVA], or systemic therapy).
- •Negative chest x-ray and purified protein derivative (PPD) within 1 month.
- •Understand and be able to adhere to dosing and visit schedules.
- •Screening laboratory tests must meet protocol-specified criteria.
- •Women and men of childbearing potential must be using adequate birth control measures and should continue such precautions for 6 months after last infusion of infliximab.
排除标准
- •Pregnant, nursing, or planned pregnancy within 6 months after last scheduled treatment.
- •Used topical corticosteroids in previous 14 days or systemic therapy (phototherapy UVb [UVB], PUVA, cyclosporine, methotrexate) in previous 28 days, or received treatment with anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, human or murine immunoglobulins, TNF-alpha receptor fusion proteins, or other bioengineered fusion proteins.
- •Received previous immunobiologics.
- •Have HIV, hepatitis B or C.
- •Recently transplanted (exception - corneal transplant >3 months prior to first infusion) or known malignancy or history of malignancy within previous 5 years (exception - basal or squamous cell carcinoma of skin that has been treated with no evidence of recurrence).
- •Concurrent medications that are not permitted.
- •congestive heart failure (CHF)
- •Use of cyclosporine or tacrolimus within 4 weeks prior to Screening.
- •Use of intramuscular (IM), intravenous (IV), or oral corticosteroids within 4 weeks prior to Screening.
- •Treatment with any investigational drug within 3 months prior to Screening.
- •Allergy to murine proteins.
- •Serious infections (hepatitis, pneumonia, pyelonephritis) in previous 3 months.
- •History of active tuberculosis (TB) requiring treatment within previous 3 years, or history of opportunistic infections (herpes zoster) within 2 months of Screening.
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
- •Current signs or symptoms of other severe uncontrolled disease which in investigator's opinion would put the subject at an unacceptable risk.
- •History of current alcohol or drug abuse.
- •Not observed designated washout periods for any of the prohibited medications in protocol.
结局指标
主要结局
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10
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 response 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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