A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)
研究概览
简要总结
The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.
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
- Double (Participant, Investigator)
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
secukinumab 10 mg/kg i.v. loading
secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
干预措施: secukinumab (AIN457) (Biological)
secukinumab 10 mg/kg i.v. loading
secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
干预措施: placebo (Drug)
placebo
placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
干预措施: placebo (Drug)
secukinumab 150 mg s.c. loading
secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
干预措施: secukinumab (AIN457) (Biological)
secukinumab 150 mg s.c. loading
secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
干预措施: placebo (Drug)
placebo
placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
干预措施: secukinumab (AIN457) (Biological)
结局指标
主要结局
Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)
时间窗: 12 weeks
A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
次要结局
- Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR)(baseline, 12 weeks)
- Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.(baseline, 12 Weeks)
- Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)(baseline, 12 weeks)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response(baseline, 12 weeks)
- Percentage of Participants Who Achieve ACR50 and ACR70(12 weeks)
- Change From Baseline in Swollen 66-joint Count(baseline, 12 weeks)
- Change From Baseline in Tender 68-joint Count(baseline, 12 weeks)
- Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain(baseline, 12 weeks)
- Change From Baseline in Participant's Global Assessment of Disease Activity(baseline, 12 weeks)
- Change From Baseline in Physician's Global Assessment of Disease Activity(baseline, 12 weeks)
- Change From Baseline in hsCRP(baseline, 12 weeks)
- Change From Baseline in ESR(baseline, 12 weeks)