RECRUITINGOBSERVATIONAL
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
About This Trial
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form -
Who Should NOT Join This Trial:
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 conditions (where your immune system attacks your own body)s (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 -
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 -
Treatments Being Tested
DRUG
Telitacicept Tofacitinib
One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment
Locations (1)
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China