NCT02915159已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome
Bristol-Myers Squibb104 个研究点 分布在 8 个国家目标入组 250 人开始时间: 2016年12月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 104
- 主要终点
- Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.
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
- •EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5
- •Positive anti-SS-A/Ro antibody at screening
- •meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)
排除标准
- •Secondary Sjögrens syndrome
- •Active life-threatening or organ-threatening complications of Sjögren's-syndrome
- •Other medical condition associated with sicca syndrome
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
时间窗: Day 169
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA) Overall score, which can range from 0 to 123, a higher score indicates more disease activity
次要结局
- Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)(Day 169)
- Change From Baseline in the Stimulated Whole Salivary Flow(Day 169)
- Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline at All Measured Time Points in the ESSPRI(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in Components of ESSDAI(Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169)
- Change From Baseline in ESSPRI Components(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in Tear Break-up Time(Day 85, Day 169)
- Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in Schirmer's Test(Day 85, Day 169)
- Laboratory Marked Abnormalities: Double Blind Period(Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.)
- Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in Numeric Rating Scale for Eye Dryness(Day 1, 29, 57, 85, 113, 141, 169)
- Change From Baseline in Physician Global Assessment of Disease Activity(Day 29, 57, 85, 113, 141, 169)
- Summary of Adverse Events: Double Blind Period(Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.)
- Change From Baseline at All Measured Time Points in the ESSDAI(Day 29, Day 57, Day 85, Day 113, Day 141, Day 169)
- Change From Baseline in the Ocular Staining Score (OSS)(Day 85, Day 169)
- Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period(Day 365, post open label treatment day 85)
- Laboratory Marked Abnormalities: Cumulative Abatacept Period(Day 365 and 3 months of follow up approximately 450 Days)
- Change From Baseline in Unstimulated Salivary Flow(Day 85, Day 169)
- Change From Baseline in Stimulated Salivary Flow(Day 85, Day 169)
- Geometric Mean of Trough Concentration (Cmin) of Abatacept(Day 29, 85, 113, 141, 169)
- Summary of Adverse Events: Cumulative Abatacept Period(Day 365 and 3 months of follow up approximately 450 Days)
- Change From Baseline in Numeric Rating Scale for Mouth Dryness(Day 1, 29, 57, 85, 113, 141, 169)
- Change From Baseline in Participant Assessment of Disease Activity(Day 29, 57, 85, 113, 141, 169)
- Change From Baseline in Patient Fatigue(Day 29, 57, 85, 113, 141, 169)
- Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)(Day 85, Day 169)
- Change From Baseline in 36-item Short Form Health Survey (SF-36)(Day 85, Day 169)
- Percentage of Participants With a Positive Antibody Response(Day 85 db, day 169 db, post treatment day 85)
研究者
研究点 (104)
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