NCT02362074已完成不适用
Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis.
AbbVie32 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2015年1月21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
- 401
- 试验地点
- 32
- 主要终点
- Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)
研究概览
简要总结
The purpose of this study is to describe the impact of treatment with adalimumab on work related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated in Canada.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab
- •Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS
- •Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB
- •Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol.
排除标准
- •Subject cannot or will not sign a patient authorization
- •Subject with a known hypersensitivity to Adalimumab, or any of its components
- •Presence of any condition that, in the opinion of the treating physician, prohibits the subject from participating in the study or obscures the assessment of the treatment of RA
- •Subjects currently participating in an investigational clinical trial
- •Subjects treated with >1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited
- •Subjects previously treated with targeted synthetic disease modifying agent.
结局指标
主要结局
Change in Rheumatoid Arthritis-Work Instability Scale (RA-WIS)
时间窗: From Month 0 to Month 6
This is patient-reported assessment on the impact of adalimumab on the work status of RA patients.
Change in Financial Loss
时间窗: From Month 0 to Month 6
This is patient reported assessment of financial burden of RA.
次要结局
- Change in the Financial Loss(From Month 0 to Month 12, 18 and 24)
- Change in Rheumatoid Arthritis-Work Instability (RA-WIS)(From Month 0 to Month 12, 18 and 24)
- Rate of Achieving Low Disease Activity (LDA) per CDAI(From Month 0 to Month 24)
- Change in patient pain(From Month 0 to Month 24)
- Change in Swollen Joint Count (SJC)(From Month 0 to Month 24)
- Change in c-reactive protein (CRP)/erythrocyte sedimentation rate (ESR)(From Month 0 to Month 24)
- Change in Tender Joint Count (TJC)(From Month 0 to Month 24)
- Change in Disease Activity Score (DAS) 28(From Month 0 to Month 24)
- Change in Health Assessment Questionnaire (HAQ)(From Month 0 to Month 24)
- Change in patient assessment of Global Disease Activity(From Month 0 to Month 24)
- Change in physician's assessment of Global Disease Activity(From Month 0 to Month 24)
- Rate of Achieving Low Disease Activity (LDA) per Disease Activity Score (DAS) 28(From Month 0 to Month 24)
- Rate of Remission per Simplified Disease Activity Index (SDAI)(From Month 0 to Month 24)
- Rate of Remission per Disease Activity Scale (DAS) 28(From Month 0 to Month 24)
- Rate of Remission Per Clinical Disease Activity Index (CDAI)(From Month 0 to Month 24)
- Rate of Achieving Low Disease Activity (LDA) per SDAI(From Month 0 to Month 24)
研究者
研究点 (32)
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