Pan-EU Real-World Experience With Imraldi®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Candidate Predictors of Persistence on Adalimumab
研究概览
简要总结
The primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (Imraldi®) participants diagnosed with immune-mediated inflammatory disease in Europe (EU).
The secondary objectives of this study are to describe participant clinical characteristics at baseline, utilization of Imraldi® over time, biologic drug effectiveness over time, participant satisfaction with biologic administration, routine laboratory values and clinical evaluation measurements over time, use of relevant concomitant medication use over time, immunogenicity of biosimilars and to summarize safety events.
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
- •Initiation on Imraldi® therapy after 18th October 2018, as part of routine treatment immediately after transitioning from at least 16 weeks' treatment with originator adalimumab (Humira®)
- •Availability of at least one Baseline disease score (i.e. within 16 weeks prior or up to 6 weeks post-initiation of Imraldi®)
- •Should provide informed consent to participate in the study
排除标准
- •Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator
研究组 & 干预措施
Adalimumab Therapy
Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy
干预措施: Adalimumab (Drug)
结局指标
主要结局
Candidate Predictors of Persistence on Adalimumab
时间窗: Baseline up to Week 48
Candidate predictors (baseline clinical characteristics, disease score as applicable, incidence and clinical management of flares, and patient satisfaction survey) will be assessed via cox regression which will result in a hazard ratio.
次要结局
- Change from Baseline in Disease Scores as Applicable by Indication(Baseline up to Week 48)
- Patient Satisfaction with Biologic Administration(Baseline up to Week 48)
- Number of Participants with Serious Adverse Events (SAEs) and Causally-related Non-serious Adverse Events (AEs)(Baseline up to Week 48)
- Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements(Baseline up to Week 48)
- Number of Participants by Utilization of Relevant Concomitant Medication Categories(Baseline up to Week 48)
- Number of Participants by Baseline Clinical Characteristic Categories(Baseline)
- Number of Participants by Utilization of Adalimumab Categories(Baseline up to Week 48)
- Number of Participants with Anti-drug Antibodies(Baseline up to Week 48)