A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response
研究概览
简要总结
A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China.
详细描述
This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered subcutaneously (SC). Adalimumab effectiveness will be assessed based on data from clinic visits beginning at Baseline and continuing per standard of care for RA. The primary objective is to evaluate the effectiveness of adalimumab in improving patients' disease activity measured by Disease Activity Score (DAS28) at Week 12. The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. The study was terminated due to low enrollment.
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
- •Male or female patient greater than or equal to 18 years of age with diagnosis of RA (Rheumatoid Arthritis) and no history of chronic arthritis before age
- •Patient meets the requirements for treatment with adalimumab per the local product label.
- •Patient is naïve to adalimumab, and has not used any other immunomodulatory biologic* DMARD (Disease Modifying Antirheumatic Drugs) in the past 8 weeks before the Baseline visit (*rituximab may not have been used in the past 104 weeks before the Baseline visit).
- •Patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by Abbott.
排除标准
- •Patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline visit.
- •Prior clinically active TB (tuberculosis): if patient has had prior clinically active TB, there should be documentation that a full course of appropriate anti-TB therapy was completed or an ongoing full course of appropriate anti-TB therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study.
- •Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab.
- •Patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the Investigator determines that they should not be enrolled based on his/her clinical judgment.
结局指标
主要结局
Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response
时间窗: Week 12
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1
次要结局
- Percent Change From Baseline in Tender and Swollen Joint Counts(Weeks 4, 8, 12, 26)
- Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Weeks 4, 8, 12, 26)
- Percent Change From Baseline in Patient's Global Assessment of Disease Activity(Weeks 4, 8, 12, 26)
- Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)(Weeks 4, 8, 12, 26)
- Percent Change From Baseline in C-reactive Protein(Weeks 4, 8, 12, 26)
- Percent Change From Baseline in Patient's Assessment of Pain(Weeks 4, 8, 12, 26)
- Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity(Weeks 4, 8, 12, 26)
- Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)(Weeks 4, 8, 12, 26)