Telitacicept plus baricitinib for refractory rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study at Zhejiang Provincial People's Hospital will follow adults with difficult-to-treat rheumatoid arthritis who are being prescribed telitacicept combined with baricitinib as part of routine care. Researchers will collect clinical measures of disease activity, laboratory safety tests, adverse events, and treatment adherence during scheduled clinic visits. There is no randomization or blinding; outcomes will be compared to patients' baseline status and clinical expectations. The focus is on real-world effectiveness and tolerability of the combination in a single-center setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Zhenhua Ying
• Email: yingzh2021@163.com
• Phone: +86-571-3989897128

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

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• Telitacicept for difficult-to-treat rheumatoid arthritis

  This study tests whether adding telitacicept to standard therapy helps adults with hard-to-treat rheumatoid arthritis see better control of their symptoms.

  Recruiting Phase 2 Peking University People's Hospital · Hefei, Anhui and 46 other locations · NCT07796516

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.