BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Janssen Inc.
- 入组人数
- 2,821
- 主要终点
- Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab
研究概览
简要总结
This registry is a multi-center, prospective, longitudinal, observational program that will gather and analyse data on participants treated with infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab. Treatment will be prescribed by the physician according to actual clinical practice or standard of care for Rheumatoid Arthritis (RA), Axial Spondyloarthritis (AxSpA) , Psoriatic Arthritis (PsA); there will be no randomized assignments to treatment. At baseline and approximately every 6 months thereafter, information will be collected to assess safety, clinical outcomes, quality of life, comorbidities, pharmacoeconomics and treatment regimens among cohorts of participants receiving infliximab, golimumab, golimumab I.V or ustekinumab for the treatment of RA, AxSpA and PsA.
详细描述
Participants will be selected for this registry using a non-probability sampling method.
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
- •Participant is starting infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab at the time of enrollment and is biologic naive or has been treated with only one prior biologic (including infliximab, golimumab, golimumab I.V or ustekinumab) prior to enrollment
- •Participant has signed the approved informed consent form
- •Participant is diagnosed with RA, AxSpA or PsA and is eligible for treatment with infliximab, golimumab, golimumab I.V or ustekinumab in accordance with routine clinical care and the Canadian Product Monograph.
排除标准
- •Participant was treated with two or more biologics, for any period of time before enrollment
结局指标
主要结局
Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab
时间窗: Up to 4 years
Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
Disease Status of Canadian Participants With Rheumatic Disease Treated With Golimumab Intravenous (I.V)
时间窗: Up to 4 years
Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
Disease Status of Canadian Participants With Rheumatic Disease Treated With Ustekinumab
时间窗: Up to 4 years
Physician will rate arthritis activity using VAS ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
Disease Status of Canadian Participants With Rheumatic Disease Treated With Infliximab
时间窗: Up to 4 years
Physician will rate arthritis activity using Visual Analog Scale (VAS) ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
次要结局
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab(Up to 4 years)
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Infliximab(Up to 4 years)
- The Number of Participants With Adverse Events(Up to 4 years)
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Golimumab I.V(Up to 4 years)
- Expanded Information and Support for Healthcare Providers and Hospitals About the Appropriate use of Ustekinumab(Up to 4 years)