NCT07491016招募中不适用
A Study on the Clinical Efficacy and Safety of Telitacicept Combined With Baricitinib in the Treatment of Difficult-to-Treat Rheumatoid Arthritis (D2T RA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of Telitacicept Combined With Baricitinib 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 baricitinib 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
- •1. 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
- •1. 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 Baricitinib 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
Chief Physician
Zhejiang Provincial People's Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Effect of 60ml Sahacharadi Taila Matra Basti in The management of PCODCTRI/2024/06/069634Dr Ashvini Zore30
招募中
1 期
UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological DiseasesAutoimmune Hemolytic AnemiaNCT07441525Union Hospital, Tongji Medical College, Huazhong University of Science and Technology27
尚未招募
1 期
UGX202 Injection in Patients With Advanced Retinitis PigmentosaNCT07311863Suzhou UgeneX Therapeutics Co., Ltd.6
尚未招募
1 期
QLS5132 Combination Therapy in Advanced Solid TumorsOvarian CancerNCT07453394Qilu Pharmaceutical Co., Ltd.626
尚未招募
1 期
Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel DiseaseNCT07309744Union Hospital, Tongji Medical College, Huazhong University of Science and Technology30