Tofacitinib treatment for IgG4-related disease
Clinical Study on the Efficacy and Safety of Tofatib and Cyclophosphamide in the Treatment of Active IgG4 Related Diseases
This study is testing whether tofacitinib can help people with active IgG4-related disease get better compared to a traditional treatment called cyclophosphamide.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | tofacitinib, cyclophosphamide |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05625581 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of tofacitinib compared to cyclophosphamide in inducing remission in patients with active IgG4-related disease. It is a prospective, single-center, non-randomized, controlled, open-label study where patients receive either glucocorticoids combined with tofacitinib or glucocorticoids combined with cyclophosphamide. The study aims to enroll at least 20 patients in each treatment group over a 6-month period, assessing remission rates and other clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with active IgG4-related disease who meet specific inclusion criteria.
Not a fit: Patients with IgG4-related diseases that threaten organ function or life, or those with certain medical histories, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with IgG4-related disease.
How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in treating autoimmune diseases with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * It meets the 2019 ACR/EULAR classification diagnostic criteria for IgG4 related diseases, and is an active IgG4-RD, defined as an IgG4-RD RI score ≥ 3 points when screening Exclusion Criteria: * 1. IgG4 related diseases endangering organ function or life; 2. Only Mikulicz disease, no other internal organs involved; 3. People with history of thrombotic disease or high risk of thrombosis; 4. Have a history of malignant tumor; 5. Active infection; 6. Pregnant or lactating women;
Where this trial is running
Shanghai, Shanghai
- Shanghai Changhai Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Gao Jie, doctor
- Email: gaojif@qq.com
- Phone: 13585561861
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.