Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- clinical remission defined by DAS28
研究概览
简要总结
Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years
详细描述
This is a multi-center, prospective, real-world observational study. Patients who have completed 6 months of induction therapy (YISAIPU 50mg / week ± csDMARDs) and achieved clinical remission or low disease activity will be observed for 2.5 years. During the maintenance period, through full communication between doctors and patients, YISAIPU 50 mg/wk or YISAIPU 25 mg/wk will be chosen as maintenance treatment. The clinical efficacy evaluation parameters include DAS28, HAQ-DI, modified Sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. Drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of YISAIPU due to adverse events. Exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of Interstitial Lung Disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Meet the ACR revised RA classification criteria(2010);
- •Disease duration is more than or equal to 6 weeks;
- •DAS28-CRP>2.6;
- •Patient is eligible for TNF inhibitors treatment according to the judgment of the attending doctor in clinical practice;
- •A written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure.
排除标准
- •Exclusion criteria:
- •Patient has contraindication(s) to the use of fusion-protein type of TNF inhibitor;
- •Patient is participating in other ongoing drug clinical trials;
- •Patient whose LTBI screening result is positive, or had not received standard anti-TB treatment for TB history, is unwilling to take prophylactic treatment for TB;
- •Patient with HBV infection and positive for HBV replication (not up to active replication) is not willing to receive anti-HBV treatment;
- •Anti-HCV antibody is positive and HCV-RNA is positive, and patient is unwilling to start anti-HCV treatment;
- •Other reasons the researchers think the patient is not eligible for participation in the study.
研究组 & 干预措施
RA Patients receiving routine treatment
During the induction phase, the dose of YISAIPU is 50mg/wk. Patients who achieved clinical remission or low activity after 24 weeks of induction treatment can enter the maintenance phase. Those who fail to succeed in induction treatment will not be followed up. During the maintenance phase, the dose of YISAIPU could be either 50mg/wk or 25mg/wk. Patients will be followed up regularly for 2.5 years.
干预措施: YISAIPU® ( An etanercept biosimilar) (Drug)
RA Patients receiving routine treatment
During the induction phase, the dose of YISAIPU is 50mg/wk. Patients who achieved clinical remission or low activity after 24 weeks of induction treatment can enter the maintenance phase. Those who fail to succeed in induction treatment will not be followed up. During the maintenance phase, the dose of YISAIPU could be either 50mg/wk or 25mg/wk. Patients will be followed up regularly for 2.5 years.
干预措施: csDMARDs (Drug)
结局指标
主要结局
clinical remission defined by DAS28
时间窗: 48 weeks
Clinical efficacy: Clinical remission rate achieved at 48 weeks
次要结局
- clinical remission rate of RA at weeks 24, 96 and 144(weeks 24, 96 and 144)
- changes of carotid intima-media thickness at weeks 48 and 144(weeks 48 and 144)
- low disease activity rate of RA at weeks 24, 48, 96 and 144(weeks 24, 48, 96 and 144)
- joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144(weeks 24, 48, 96 and 144)
- improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144(weeks 24, 48, 96 and 144)
- scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144(weeks 24, 48, 96 and 144)
- rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144(weeks 24, 48, 96 and 144)