NCT05240859Unknown不适用
A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in 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
- 1,600
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving American College of Rheumatology (ACR) 20
研究概览
简要总结
The purpose of this multicenter, prospective, Observational study is to assess the Efficacy and Safety of an Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis in the real world setting.
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
- •Participants who fulfilled the 1987 revised American College of Rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA.
- •Participants for whom the rheumatologists have decided to initiate Geleli treatment.
- •Participants who provide a written informed consent form of participating in this study.
排除标准
- •Current active or chronic infections, or previous history of active TB infection.
- •History of malignancy.
- •Congestive heart failure with NYHA class III or IV.
- •Females of childbearing or breastfeeding.
- •Participate in other clinical trial within 3 months.
- •Allergic to the drugs involved in the study.
- •The investigator believes that the patient is not suitable to participate in this study.
研究组 & 干预措施
Geleli
RA patients treated with Geleli
干预措施: Geleli (Drug)
结局指标
主要结局
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
时间窗: Week 24
The ACR20 was achieved if there was at least a 20% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP.
次要结局
- Proportion of Participants Achieving American College of Rheumatology (ACR) 20(Week 4 and Week 12)
- Remission rate According to Clinical Disease Activity Index (CDAI)(Week 12 and Week 24)
- Percentage of Participants Who Were on Geleli for a Period of 24 Weeks(Week 24)
- Remission rate According to Boolean Criteria(Week 12 and Week 24)
- Change From Baseline in Disease Activity Score 28 (DAS28)-ESR(Baseline, Week 4, Week12 and Week 24)
- Assessment of Safety Based on Adverse Events that Occur During the Study.(24 weeks)
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)(Baseline, Week 4, Week12 and Week 24)
- Proportion of Participants Achieving American College of Rheumatology (ACR) 50(Week 4, Week 12 and Week 24)
- Proportion of Participants Achieving American College of Rheumatology (ACR) 70(Week 4, Week 12 and Week 24)
研究者
研究点 (1)
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