Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Combining telitacicept and tofacitinib for treating difficult rheumatoid arthritis

Official title: Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib

Run by Zhejiang Provincial People's Hospital · NCT06979271 · Data updated 2026-11-12

This study tests if combining two medications, telitacicept and tofacitinib, can help adults with tough-to-treat rheumatoid arthritis feel better when other treatments haven't worked.

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment20 (estimated)
SponsorZhejiang Provincial People's Hospital
Academic / other
Drugs / interventionstofacitinib
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJune 1, 2025
Main results expectedApril 30, 2026
Study endsApril 30, 2027
Registry record updatedMay 18, 2025
Trial IDNCT06979271 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-85 with a diagnosis of refractory rheumatoid arthritis who have not benefited from previous treatments.

Probably not a fit

Patients with severe organ diseases, malignancies, or other autoimmune disorders may not benefit from this study.

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 aims to evaluate the clinical efficacy and safety of telitacicept when used in combination with tofacitinib for patients suffering from refractory rheumatoid arthritis. Participants will be adults aged 18-85 who have not responded to traditional treatments and require this specific combination therapy. The study will monitor treatment outcomes and any adverse effects experienced by the participants over the course of the treatment.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with refractory rheumatoid arthritis who have not responded to existing therapies.

How similar studies have gone: While this specific combination has not been extensively tested, similar approaches in treating refractory rheumatoid arthritis have shown promise in other studies.

Who can join: the full rules

Show full inclusion / exclusion 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 -

Where it's running

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

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.