NCT03457792已完成不适用
Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2018年4月17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
- 158
- 试验地点
- 1
- 主要终点
- Number of patients continuing with abatacept treatment
研究概览
简要总结
This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
- •Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)
排除标准
- •Participants who are currently included in any interventional clinical trial in RA
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of patients continuing with abatacept treatment
时间窗: Up to 12 months
次要结局
- Clinical disease activity index (CDAI)(Up to 12 months)
- Reason for abatacept treatment initiation as determined by the investigator(At baseline)
- Socio-demographics of participants as determined by the investigator(At baseline)
- Concomitant treatment given with abatacept as determined by the investigator(Up to 12 months)
- Dosage of abatacept as determined by the investigator(Up to 12 months)
- Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)(Up to 12 months)
- Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)(Up to 12 months)
- Simplified Disease Activity Score (based on 28 joints) (DAS28)(Up to 12 months)
- Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2(Up to 12 months)
- Anti-citrullinated protein antibody (ACPA) titer(At baseline)
- Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)(Up to 12 months)
- Number of Adverse Events (AE)(Up to 12 months)
- Evaluator global assessment (EGA)(Up to 12 months)
- Frequency of administration of abatacept(Up to 12 months)
- Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)(Up to 12 months)
- Patient global assessment (PGA)(Up to 12 months)
- Disease history of participants as determined by the investigator(At baseline)
- Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria(Up to 12 months)
- Number of patients who achieve the first remission state, DAS28 < 2.6(Up to 12 months)
- Number of Serious Adverse Events (SAE)(Up to 12 months)
- Existence or the absence of radiographic erosions as determined by the investigator by imaging technique(Up to 12 months)
- Rheumatoid factor (RF)(Up to 12 months)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to 12 months)
- Simple disease activity index (SDAI)(Up to 12 months)
研究者
研究点 (1)
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