NCT06979271招募中不适用
Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
研究概览
简要总结
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
- •The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease-improving anti-rheumatic drugs is ineffective, and telitacicept combined with tofacitinib is required treated patients
- •Voluntarily provided written informed consent -
排除标准
- •Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
- •Patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis)
- •History of allergy/hypersensitivity to the study medications (Telitacicept or Tofacitinib)
- •Active tuberculosis or active infectious diseases requiring systemic treatment
- •Pregnancy, lactation, or refusal to use contraception during the study
- •Failure to complete the prescribed Telitacicept + Tofacitinib regimen due to: Non-adherence or Severe adverse reactions
- •Other conditions contraindicating participation per investigator judgment -
结局指标
主要结局
Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
时间窗: maximum 1 years
The disease activity score of 28 joints with erythrocyte sedimentation rate (DAS28-ESR ≤ 2.6, remission; 2.6 \< DAS28-ESR ≤ 3.2, mild activity; 3.2 \< DAS28-ESR ≤ 5.1, moderate activity, and DAS28-ESR \> 5.1, severe activity)
次要结局
- Incidence of Treatment-Emergent Adverse EventsArthritis(maximum 1 years)
研究者
Zhenhua Ying
Director
Zhejiang Provincial People's Hospital
研究点 (1)
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