Telitacicept plus 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)
This test tries combining telitacicept with baricitinib to see if it helps adults with refractory rheumatoid arthritis who haven't improved on other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Drugs / interventions | tofacitinib, baricitinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07491016 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–85 with refractory rheumatoid arthritis per the 2021 EULAR criteria who have failed conventional DMARDs and at least two biologic or targeted therapies and who are planned to receive telitacicept plus baricitinib may qualify.
Not a fit: Patients with severe organ dysfunction, active infections including tuberculosis, malignancy, other autoimmune diseases, pregnancy or lactation, or known allergy to the study drugs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combination could offer a new treatment option that reduces disease activity for patients with refractory rheumatoid arthritis.
How similar studies have performed: Telitacicept and baricitinib have shown efficacy individually in autoimmune disease and RA respectively, but the specific combination remains novel with limited published data.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Zhenhua Ying
- Email: yingzh2021@163.com
- Phone: +86-571-3989897128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.