NCT03011281Unknown不适用
Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
研究概览
简要总结
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •A. Patients who do not provide a written informed consent form of participating in this study
研究组 & 干预措施
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.
干预措施: Tofacitinib (Drug)
结局指标
主要结局
DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
时间窗: 5 years
次要结局
- Assessment of efficacy with Simple Disease Activity Index (SDAI)(5 years)
- Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))(5 years)
- Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)(5 years)
- Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria(5 years)
- Assessment of safety based on adverse events that occur during 5 years of patient monitoring.(5 years)
- 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.(5 years)
- Global Health assessment using Visual Analogue Scale (VAS)(5 years)
- Assessment of sleep disturbance using Visual Analogue Scale (VAS)(5 years)
- Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)(5 years)
- Assessment of efficacy with Clinical Disease Activity Index (CDAI)(5 years)
- Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)(5 years)
研究者
Yoon-Kyoung Sung
Associate professor
Hanyang University
研究点 (1)
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