Telitacicept Tofacitinib: One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment
Study summary
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-85 years
2. Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
3. 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
4. Voluntarily provided written informed consent -
Exclusion Criteria:
1. Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
2. Patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis)
3. History of allergy/hypersensitivity to the study medications (Telitacicept or Tofacitinib)
4. Active tuberculosis or active infectious diseases requiring systemic treatment
5. Pregnancy, lactation, or refusal to use contraception during the study
6. Failure to complete the prescribed Telitacicept + Tofacitinib regimen due to: Non-adherence or Severe adverse reactions
7. Other conditions contraindicating participation per investigator judgment -
Primary outcome measure(s)
Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis — 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)
Trial sites (1)
Facility
City
Region
Status
Zhejiang Provincial People's Hospital
Hangzhou
Zhejiang
Recruiting
More Zhejiang Provincial People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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