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Recruiting Observational

Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis

NCT07491016 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-03-01
Last updated
2026-03-30

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Recruiting
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