Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting.
- To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
- To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
- To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Seoul、大韩民国、04763
- 招聘中
- Hanyang University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
A. Patients who provide a written informed consent form of participating in this study.
B. Patients who are more than 19 years old. C. Patients with moderately to severely active rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response or are intolerant to methotrexate.
Exclusion Criteria:
A. Patients who do not provide a written informed consent form of participating in this study
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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RA patients who start Tofacitinib
Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics.
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
大体时间：5 years
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5 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))
大体时间：5 years
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5 years
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Assessment of safety based on adverse events that occur during 5 years of patient monitoring.
大体时间：5 years
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5 years
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Assessment of adherence with Patient-reported Adherence, and Medication Possession Ratio (MPR) at 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 weeks of clinical visit.
大体时间：5 years
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5 years
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Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)
大体时间：5 years
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5 years
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Global Health assessment using Visual Analogue Scale (VAS)
大体时间：5 years
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5 years
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Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)
大体时间：5 years
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5 years
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Assessment of sleep disturbance using Visual Analogue Scale (VAS)
大体时间：5 years
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5 years
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Assessment of efficacy with Simple Disease Activity Index (SDAI)
大体时间：5 years
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5 years
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Assessment of efficacy with Clinical Disease Activity Index (CDAI)
大体时间：5 years
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5 years
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Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria
大体时间：5 years
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5 years
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Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)
大体时间：5 years
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5 years
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合作者和调查者
调查人员
- 首席研究员：Yoon-Kyoung Sung, MD, PhD, MPH、Hanyang University Hospital for Rheumatic Diseases
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Tofacitinib的临床试验
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Charite University, Berlin, Germany招聘中
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Oregon Health and Science UniversityPfizer完全的
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Vastra Gotaland Region主动，不招人