RecruitingNCT06979271
Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib
Sponsor
Zhejiang Provincial People's Hospital
Enrollment
20 participants
Start Date
Jun 1, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria4
- 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 Criteria7
- 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 -
Interventions
DRUGTelitacicept Tofacitinib
One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06979271
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