Combining telitacicept and tofacitinib for treating difficult rheumatoid arthritis
Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib
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 type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Drugs / interventions | tofacitinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06979271 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with a diagnosis of refractory rheumatoid arthritis who have not benefited from previous treatments.
Not a fit: Patients with severe organ diseases, malignancies, or other autoimmune disorders may not benefit from this study.
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 performed: While this specific combination has not been extensively tested, similar approaches in treating refractory rheumatoid arthritis have shown promise in other studies.
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)
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.