A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 301
- 试验地点
- 80
- 主要终点
- Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12
研究概览
简要总结
Primary objective:
- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)
Secondary objectives:
-
to demonstrate that Sarilumab was effective on:
-
assessment of higher level of response [ASAS 40% response criteria (ASAS40)]
-
partial remission
-
disease activity
-
range of motion
-
Magnetic Resonance Imaging (MRI) of the spine
-
to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
详细描述
The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（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
Placebo
Placebo (for sarilumab) weekly (qw) for 12 weeks.
干预措施: Placebo (Drug)
Sarilumab 100 mg q2w
Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks.
干预措施: Sarilumab (Drug)
Sarilumab 100 mg q2w
Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks.
干预措施: Placebo (Drug)
Sarilumab 150 mg q2w
Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
干预措施: Sarilumab (Drug)
Sarilumab 150 mg q2w
Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
干预措施: Placebo (Drug)
Sarilumab 100 mg qw
Sarilumab 100 mg SC injection qw for 12 weeks.
干预措施: Sarilumab (Drug)
Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
干预措施: Sarilumab (Drug)
Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
干预措施: Placebo (Drug)
Sarilumab 150 mg qw
Sarilumab 150 mg SC injection qw for 12 weeks.
干预措施: Sarilumab (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12
时间窗: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index \[BASFI\]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.
次要结局
- Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12(Baseline to Week 12 (LOCF))
- Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12(Baseline to Week 12 (LOCF))
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12(Baseline, Week 12 (LOCF))
- Change From Baseline in BASDAI Score at Week 12(Baseline, Week 12 (LOCF))
- Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12(Baseline, Week 12 (LOCF))
- Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12(Baseline, Week 12)
- Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12(Baseline to Week 12 (LOCF))
- Change From Baseline in Chest Expansion at Week 12(Baseline, Week 12 (LOCF))
- Change From Baseline in Swollen Joint Index at Week 12(Baseline, Week 12 (LOCF))
- Change From Baseline in Hs-CRP at Week 12(Baseline, Week 12 (LOCF))
- Change From Baseline in ASAS Individual Components at Week 12(Baseline, Week 12 (LOCF))