Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,013
- 主要终点
- Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
研究概览
简要总结
The purpose of this study is to evaluate the clinical effectiveness and safety of adalimumab as used in routine clinical practice in adult participants with moderate to severe rheumatoid arthritis (RA) in Canada.
详细描述
REACH is an observational survey of participants with moderate to severe rheumatoid arthritis taking adalimumab. Participants who volunteer will be asked to provide information about their medical history and experiences with adalimumab. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.
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 eligible to take part in the registry as per the product monograph.
- •Participants that are naïve to adalimumab therapy / or participants that have been receiving adalimumab therapy for less than 4 months.
- •Participant has moderately to severely active RA.
- •Participant who has had an inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs).
- •Participant received provincial or private (insurance companies) approval for adalimumab.
- •Participant is able to give written informed consent and to understand the survey requirements.
排除标准
- •Participant to whom a traditional DMARD had never been tried.
- •Participant with a known hypersensitivity to adalimumab, or any of its components.
- •Participant is receiving free adalimumab as part of a compassionate program or an early access drug distribution program.
- •Participant with clinically significant concurrent medical or psychiatric disorders that may influence survey outcomes.
- •Participant with any condition that would prevent participation in the survey and completion of the survey procedures including language limitation or possibility that the participant will not be available for a period of time (> 12 months) while being enrolled in the survey.
结局指标
主要结局
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
时间窗: Month 0, 6, 12, 18 and 24
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 \[low activity\] to 10 \[high activity\]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
次要结局
- Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)(Month 0, 6, 12, 18 and 24)
- Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)(Month 0, 6, 12, 18 and 24)