A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 344
- 试验地点
- 12
- 主要终点
- Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
研究概览
简要总结
Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
详细描述
Adults with active ankylosing spondylitis (AS) were randomized in a 2:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or matching placebo, given subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could enter the 12-week open-label (OL) phase, during which all participants received treatment with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new adverse events (AEs).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 through 65 years
- •Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria
- •Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits:
- •BASDAI score at least 4 cm
- •Total back pain on a visual analog scale (VAS) at least 40 mm
- •Morning stiffness at least 1 hr
- •Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator
排除标准
- •Has total spinal ankylosis (bamboo spine)
- •Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to Baseline
- •Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel disease) that is not clinically stable, as defined by the Investigator's best clinical judgment, for at least 28 days prior to Baseline
- •Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
- •Has prior exposure to any biologic therapy with potential therapeutic impact on AS, including anti-TNF (tumor necrosis factor) therapy
结局指标
主要结局
Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
时间窗: Week 12
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).
次要结局
- Number of Participants Meeting the ASAS20 Response Criteria(Week 24)
- Number of Participants Meeting the ASAS40 Response Criteria(Week 24)
- Number of Participants Meeting the ASAS5/6 Response Criteria(Week 24)
- Number of Participants With ASAS Partial Remission(Week 24)
- Change From Baseline in Patient Global Assessment of Disease Activity(Baseline and Week 24)
- Change From Baseline in Total Back Pain Score(Baseline and Week 24)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score(Baseline and Week 24)
- Change From Baseline in Inflammation Score(Baseline and Week 24)
- Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria(Week 24)
- Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)(Baseline and Week 24)
- Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score(Baseline and Week 24)