A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
研究概览
简要总结
This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Secukinumab (75mg)
干预措施: Secukinumab (75 mg) (Drug)
Group 2
Secukinumab (150 mg)
干预措施: Secukinumab (150 mg) (Drug)
Group 3
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
时间窗: Week 24
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
次要结局
- Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline(Week 24)
- Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo(Week 24)
- Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline(Week 24)
- Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg(Week 24)
- Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg(Week 24)
- Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg(Week 24)
- Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline(Week 24)
- Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)(Week 24)
- Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline(Week 24)