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

Launched by ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of two medications, telitacicept and tofacitinib, for adults aged 18 to 85 who have refractory rheumatoid arthritis (RA). Refractory RA means that standard treatments haven't worked well for these patients. The study aims to find out if combining these two drugs can help improve their condition. To participate, individuals must have been diagnosed with RA according to specific guidelines and need to have tried other treatments without success.

Participants in this trial can expect to receive the combination of telitacicept and tofacitinib while being monitored for any side effects and overall effectiveness. It’s important to note that certain individuals will not be eligible to join, such as those with serious organ diseases, certain cancers, or those who are pregnant. If someone is interested in the study, they will need to provide written consent and agree to follow the treatment plan closely. This trial is currently recruiting participants, so it’s a good opportunity for those looking for new treatment options.

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Eligibility criteria

• 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 -