NCT02335606已完成不适用
Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2014年8月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.
研究概览
简要总结
Abatacept Registry in Taiwan
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
- •≥ 20 years of age
- •Who give informed consent
- •Confirmed diagnosis of RA (as defined by American College of Rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
- •Who self-pay or who are reimbursed by BNHI for abatacept treatment
- •With latent TB or who are receiving anti-TB treatment (INH 300 mg, QD) 1 month prior to using abatacept and continuously up to a total of 9 months Willing to follow Taiwan Risk Management Plan guidelines as required by Taiwan health authorities
- •Are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy
排除标准
- •Pregnant or breast feeding
- •With active TB
- •HBsAg (+)and/or Anti-HCV(+) and/or HBV DNA(+)
- •Have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
- •Are allergic to abatacept
- •Enrolled in other RA clinical studies
结局指标
主要结局
The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.
时间窗: approximately 24 months
Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months
次要结局
- The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients(at 6, 9, 12, 18, and 24months after study participation)
- The proportion of patients achieving DAS28 ≤ 2.6, 2.6 < DAS28 ≤ 3.2, 3.2 < DAS28 ≤ 5.1, DAS> 5.1 at 6, 9, 12, 18, and 24months(at 6, 9, 12, 18, and 24months after study participation)
- The demographic, clinical presentation, and disease management a composite measure of RA patients who are using abatacept (either formulation) or are abatacept naïve at Month 6, 9, 12, 18, and 24(at 6, 9, 12, 18, and 24months after study participation)
- The major reason for treatment discontinuation (eg, lack of efficacy, severe adverse drug reactions, switch from abatacept to another RA medication, financial issues, etc) at 6, 9, 12, 18, and 24 months(at 6, 9, 12, 18, and 24months after study participation)
- The time to treatment discontinuation in RA patients treated with abatacept(at 6, 9, 12, 18, and 24months after study participation)
研究者
研究点 (1)
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