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

Zhejiang Provincial People's Hospital

Status: Enrolling

Conditions: Telitacicept; Treatment Compliance; Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT07491016

KY2026025

Details and patient eligibility

About

The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with baricitinib in the treatment of D2TRA patients

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Telitacicept; Baricitinib. One group of D2TRA subjects receive Telitacicept combine Baricitinib