Clinical Trials in China / NCT07491016
Recruiting
Observational
Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis
NCT07491016 · tracked via the Priya Life Science China tracker
Condition(s) studied
TelitaciceptTreatment ComplianceRheumatoid Arthritis
Study summary
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with baricitinib in the treatment of D2TRA patients
Eligibility
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 Baricitinib 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
Other trials for the same condition
Official registry record
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.
View NCT07491016 on ClinicalTrials.gov ↗ ← All trials in China