Status:
RECRUITING
Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Lead Sponsor:
Zhejiang Provincial People's Hospital
Conditions:
Telitacicept
Treatment Compliance
Eligibility:
All Genders
18-85 years
Brief 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 Criteria
Inclusion
- 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 -
Exclusion
- 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 -
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06979271
Start Date
June 1 2025
End Date
April 30 2027
Last Update
May 18 2025
Active Locations (1)
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1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310000