A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 3,435
- 试验地点
- 311
- 主要终点
- Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)
研究概览
简要总结
The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.
详细描述
This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634).
Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.
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
- •Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
- •Participants must have been willing to consent to data being collected and provided to Abbott.
排除标准
- •· Participants with contraindications according to the SmPC.
结局指标
主要结局
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)
时间窗: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.
American College of Rheumatology 20% (ACR20) Response Rate
时间窗: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
American College of Rheumatology 50% (ACR50) Response Rate
时间窗: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
American College of Rheumatology 70% (ACR70) Response Rate
时间窗: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)
时间窗: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).
次要结局
未报告次要终点