Safety and Effectiveness of Biological DMARDs in Elderly Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- drug(biologics) persistency rates
研究概览
简要总结
Study objectives
- Comparison of drug persistency rates between elderly RA patients and young RA patients with biological DMARDs
- Analysis of discontinuation reasons & influencing factors of drug discontinuation in elderly RA patients and young RA patients
- Comparison of the occurrence of adverse events & treatment outcomes between elderly RA patients and young RA patients
详细描述
- Retrospective study:
We will collect data of Korean patients with RA retrospectively. Subjects will be extracted from medical records of RA patients who had treated with TNF inhibitor or are currently using TNF inhibitor. Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled.
Data for this study which are sex, date of birth, previous and current medication, the results of laboratory test, disease activity of RA (DAS28ESR), comorbidity will be collected. Information of treatment, DAS28ESR, laboratory data and SAEs will be collected at baseline and predefined time points of follow-up (0, 3 month and recent follow-up data).
During the first year of starting our study, we will focus to evaluate tolerability, the reason of discontinuation in elderly RA patients through this retrospective study. Tolerance could be analyzed by examining drug persistency of biologic DMARDs with the reason that led to drug interruption, and the drug persistency curves will be compared in the two groups. The length of time that patients remain on the drug therapy represents a useful measure of the treatment effectiveness and tolerability. The reason of discontinuation will be evaluate as descriptive analysis. And factors influenced on drug discontinuation in elderly RA patients and young RA patients using Cox-proportional analysis. 2. Prospectively study:
We will use the data of patients of Hanyang University Hospital for Rheumatic Diseases in web-based registry of RA patients with biologic DMARDs. Patients who start on receiving biologic agents including infliximab, etanercept, adalimumab, rituximab, abatacept will be enrolled. At registration, sex, date of birth, previous and current medication, the results of laboratory test, disease activity of RA (DAS28ESR), HAQ, comorbidity, socioeconomic status, etc. will be collected. Information of treatment, DAS28ESR, HAQ, laboratory data and SAEs, etc. will be collected at baseline and predefined time points of follow-up (0, 3 month and every 6 month). This prospective study will be progressed during three years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective study
- •Patients who satisfy the 1987 ACR classification criteria for RA
- •Patients with RA who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab.
- •Prospective study
- •Patients who satisfy the 1987 ACR classification criteria for RA
- •Patients with RA who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab, abatacept.
排除标准
- •Patients younger than eighteen
- •Patients enrolled in clinical trials
- •For the prospective study: Sex and Reproductive Status
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment
结局指标
主要结局
drug(biologics) persistency rates
时间窗: Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled.
The tolerability in the two groups (elderly RA patients and young RA patients) will be estimated by drug persistency rates using the Kaplan-Meier method. Comparisons between the resultant curves will be made by log rank test.
次要结局
- Treatement response (HAQ, DAS28)(Information of treatment, DAS28ESR, HAQ, laboratory data and SAEs, etc. will be collected at baseline and predefined time points of follow-up (0, 3 month and every 6 month). This prospective study will be progressed during three years.)
研究者
Sang-Cheol Bae
Professor, MD, PhD, MPH
Hanyang University