Adherence and Clinical Outcomes in Patients With e-Device for Etanercept Administration in Rheumatoid Arthritis Patients: Real Word Evidence in a Colombian Institution.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adherence (Pharmacy claims source)
研究概览
简要总结
This is a descriptive, ambispective, and single-site study in Colombia, which is designed to evaluate the adherence, persistence, and clinical outcomes (defined as the patient's disease activity and functional status) of RA patients within 40 weeks after the patient administered the first injection of the etanercept medication through the Smartclic® device. The study data seeks from medical records containing the Smartclic device injection log and pharmacy claims database available from an institution specialized in rheumatological care. The study will only include records of patients treated or starting treatment with etanercept and whose indicated autoinjection device has been Smartclic.
详细描述
Non-interventional study: The clinical records of eligible patients will be identified by the rheumatologist from the patients who attended the rheumatologist visit or institutional training sessions according to the standard of care. Patients have been prescribed etanercept according to the standard of care, and Smartclic has been indicated as an administration method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •Patients aged ≥18 years with an established diagnosis of rheumatoid arthritis according to EULAR-ACR criteria recorded in medical record.
- •Patients who are on etanercept treatment and are being switched to Smartclic, or new etanercept patients that have been prescribed Smartclic® device (either in combination with a conventional synthetic DMARD or in monotherapy).
- •Medical records and pharmacy claims database of the IPS available after the index date for a period of 40 weeks.
排除标准
- •- Any serious ongoing infections, pregnancy, or other social or medical conditions that are anticipated in the investigator's judgment to lead to discontinuation of etanercept administration with the device during the 40 weeks of data collection.
研究组 & 干预措施
Rheumatoid arthritis patients in Colombia
干预措施: Etaneracept Smartclic (Drug)
结局指标
主要结局
Adherence (Pharmacy claims source)
时间窗: Baseline through week 40
The percentage of patients with Percentage of days covered (PDC) ≥ 80%
Change From Baseline in Disease Activity Score Based on 28-joints Count with ESR (DAS28-ESR) at 40 week
时间窗: Baseline, Week 40
Change From Baseline in Functional status Based on Multidimensional Health Assessment Questionnaire (MDHAQ) at 40 week
时间窗: Baseline, Weeks 40
次要结局
- Adherence from Smartclic® injection log(Week 40)
- Persistence(Week 40)