Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Recruiting · NCT06979271 · Observational (researchers observe without assigning treatment) · Lead sponsor: Zhejiang Provincial People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Telitacicept Tofacitinib
What this trial is about
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 can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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 -
Where it is running
1 location listed.
- Zhejiang Provincial People's Hospital - Hangzhou, Zhejiang, China