A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alefacept When Given in Combination With Methotrexate in Subjects With Psoriatic Arthritis With an Open-label Retreatment Course
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70
研究概览
简要总结
Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.
详细描述
Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Psoriatic arthritis
- •MTX treatment for 3 months prior to enrollment with continuing disease
- •Normal T-cell count
排除标准
- •Other types of psoriasis
- •History of malignancy or lymphoproliferative disorder
- •Serious infection or fever
- •Antibody positive for Hepatitis C, HIV or TB
- •Hepatic transaminases > 2X normal
研究组 & 干预措施
Course A1
干预措施: Alefacept (Drug)
Course A1
干预措施: Methotrexate (Drug)
Course A2
干预措施: Methotrexate (Drug)
Course A2
干预措施: Placebo (Drug)
Course B
Open-label extension
干预措施: Alefacept (Drug)
Course B
Open-label extension
干预措施: Methotrexate (Drug)
结局指标
主要结局
Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70
时间窗: 12 Weeks and at any time
次要结局
- Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25(Each scheduled efficacy visit)
- Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear(Each scheduled efficacy visit)
- Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)(Baseline, 24 Weeks and 48 Weeks)