NCT02758769已完成不适用
Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2016年6月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept
研究概览
简要总结
The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria
- •Patients with RA with a moderate disease activity (SDAI: > 11 and 26)
- •Biologic-naive patients with treatment history csDMARDs
- •Patients who meet the following criteria by hematological examination:
- •Peripheral white blood cell count: 4,000/mm3
- •Peripheral lymphocyte count: 1,000/mm3
- •Blood β-D-glucan negative
- •Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
- •Patients initiated with abatacept at per their physician's therapeutic decision
排除标准
- •Past history of hypersensitivity to the components of the abatacept preparation
- •Disease complications from a comorbidity
- •Active infectious disease
- •Been judged by the investigator or the co-investigator as being inappropriate
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
ORENCIA with Exposure
ORENCIA with Exposure
干预措施: ORENCIA Subcutaneous Injection (Biological)
结局指标
主要结局
Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept
时间窗: 52 Weeks
次要结局
- Hospitalization rate(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in the percentage of disease activity category by clinical disease activity index(CDAI)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in Anti-citrullinated protein antibodies (ACPA)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in Rheumatoid factors (RF)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in the percentage of disease activity category by simplified disease activity index(SDAI)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Persistence rate of Abatacept treatment(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Percentage of achievement in low disease activity by simplified disease activity index (SDAI).(52 Weeks)
- Change in simplified disease activity index(SDAI)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Survival rate(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in Japanese Health Assessment Questionnaire(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in clinical disease activity index(CDAI)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Reasons for discontinuation of Abatacept treatment(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in General visual analog scale(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56)(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Number of occurrences of rheumatoid arthritis related surgery(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in European Quality of Life 5 Dimension Questionnaire(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
- Change in Pain visual analog scale(0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months)
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研究点 (2)
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