A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of remission (CDAI) at week 12
研究概览
简要总结
This will be a prospective, observational, single-arm, registry study based on data received from Chinese Registry of rheumatoid arthritis (CREDIT) database to register 200 Chinese RA patients treated with golimumab in one year. Patient characteristic, clinical effectiveness and drug adherence of golimumab will be evaluated.
详细描述
This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 18 years and older
- •Fulfil the ACR/EULAR classification criteria for RA in 2010
- •Patients able to understand and complete self-evaluation questionnaires.
排除标准
- •- Contraindications for golimumab
- •Prior exposure to TNFi/JAKi
研究组 & 干预措施
RA patients
Patients (or a representative) must provide informed consent before any procedures occur.
- Main Inclusion Criteria:
- 18 years and older
- Fulfil the ACR/EULAR classification criteria for RA in 2010
- Patients able to understand and complete self-evaluation questionnaires.
- General Exclusion Criteria:
- Contraindications for golimumab
- Prior exposure to TNFi/JAKi
干预措施: Golimumab (Drug)
结局指标
主要结局
Percentage of remission (CDAI) at week 12
时间窗: At week 12
Remission is defined as crohn's disease activity index (CDAI)≤ 2.8.
Percentage of low disease activity (CDAI) at week 12
时间窗: At week 12
Low disease activity is defined as crohn's disease activity index (CDAI)≤ 10.
次要结局
- Medication possession rate (MPR) at week 48(at week 48)
- Patient disease activity assessment (VAS) at week 12(at week 12)
- Patient Pain Global assessment (VAS) at week 12(at week 12)
- Percentage of low disease activity (DAS28-CRP) at week 12(March 1, 2021)
- Function evaluation at week 12(at week 12)
- Medication possession rate (MPR) at week 12(at week 12)
- Medication possession rate (MPR) at week 24(at week 24)