A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 65
- 主要终点
- Number of Participants With American College of Rheumatology 20 (ACR20) Response
研究概览
简要总结
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD 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
- •Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
- •Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
- •Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
- •Inadequate control of symptoms with NSAID.
- •Other protocol-defined inclusion criteria do apply.
排除标准
- •Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- •Subjects taking high potency opioid analgesics.
- •Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- •Ongoing use of prohibited psoriasis treatments / medications.
- •Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
- •Previous treatment with any cell-depleting therapies.
研究组 & 干预措施
Secukinumab 150 mg No load
Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
干预措施: Secukinumab (Biological)
Secukinumab 150 mg
Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
干预措施: Secukinumab (Biological)
Placebo
Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With American College of Rheumatology 20 (ACR20) Response
时间窗: 16 weeks
The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
次要结局
- Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16(week 16)
- Psoriatic Area and Severity Index 75 (PASI75)(16 weeks)
- Short Form Health Survey Physical Component Score (SF-36-PCS)(16 weeks)
- Number of Participants With American College of Rheumatology 50 (ACR50)(16 weeks)
- Number of Participants With American College of Rheumatology 20 (ACR20) Response(4 weeks)