RecruitingNCT07491016

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

A Study on the Clinical Efficacy and Safety of Telitacicept Combined With Baricitinib in the Treatment of Difficult-to-Treat Rheumatoid Arthritis (D2T RA)


Sponsor

Zhejiang Provincial People's Hospital

Enrollment

30 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

  • \. 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 Criteria8

  • \. 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

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Locations(1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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NCT07491016


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