NCT02598466已完成不适用
Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa
Bristol-Myers Squibb0 个研究点目标入组 69 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 主要终点
- Patterns of change in patient assessments of physical function with scores of the Health Assessment Questionnaire (HAQ) among users of SC Abatacept for RA since the commencement of a CUP in South Africa's private sector
研究概览
简要总结
Research question: what are the patterns of patient-reported changes in physical function among adult patients using SC abatacept with moderate to severe RA since commencement of the compassionate use program (CUP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The global clinical trials and associated long-term extension phases imposed inclusion and exclusion criteria. Only patients that completed the clinical trials and the long-term extension phase were eligible for inclusion in the CUP
排除标准
- 未提供
研究组 & 干预措施
Abatacept
干预措施: Abatacept (Drug)
结局指标
主要结局
Patterns of change in patient assessments of physical function with scores of the Health Assessment Questionnaire (HAQ) among users of SC Abatacept for RA since the commencement of a CUP in South Africa's private sector
时间窗: Approximately 2 years
次要结局
- Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores(Approximately 2 years)
- Demographic characteristics (age, gender, education and population group) of patients(Approximately 2 years)
- Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients(Approximately 2 years)
- Reasons for discontinuation based on the reasons mentioned in Questionnaire(Approximately 2 years)
- Reasons for skipping treatment based on the reasons mentioned in Questionnaire(Approximately 2 years)
- Changes in physical functioning against clinical trial and long-term extension phase data based incidence of adverse events(Approximately 2 years)
研究者
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