NCT03419143已完成不适用
Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2018年3月2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
- 190
- 试验地点
- 1
- 主要终点
- Disease Activity index for PSoriatic Arthritis (DAPSA)
研究概览
简要总结
The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.
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 18 years or older
- •Participants who signed an informed consent
- •Participants diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group18
- •Participants naïve of abatacept and who at their physician's discretion initiate abatacept
- •Participants meeting criteria for abatacept treatment for PsA as specified in the German label
排除标准
- •Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)
结局指标
主要结局
Disease Activity index for PSoriatic Arthritis (DAPSA)
时间窗: 12 months
次要结局
- Descriptive Analysis: Change in participant characteristics and symptoms(12 months)
- Initial dosage of Abatacept given(At Treatment Initiation)
- Participant retention rate(12 Months)
- Descriptive Analysis: Baseline Characteristics(up to 2 years prior to treatment)
- Proportion of Rheumatologist: Geography(up to 2 months prior to treatment to 12 months post treatment)
- Frequency of Abatacept administration(12 months)
- Descriptive Analysis: Reasons for Abatacept initiation(up to 2 years prior to treatment)
- Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD)(up to 2 years prior to treatment)
- Descriptive Analysis: Disease history at Treatment initiation(Prior to treatment)
- Incidence of Risk factors and Comorbidities(At Treatment Initiation)
- Proportion of Rheumatologist: Type of Institution(up to 2 months prior to treatment to 12 months post treatment)
- Proportion of reasons for abatacept discontinuation and initiation of new therapy(12 Months)
- Proportion of concomitant treatment given(12 Months)
- Descriptive Analysis: Socio-Demographics at Treatment Initiation(At Treatment Initiation)
- Proportion and type of treatment after abatacept discontinuation(12 months)
研究者
研究点 (1)
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