drugset / Trial / NCT07827469
Tofacitinib in the Treatment of IgG4 Related Diseases
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1. The primary end points of this study is to compare the IgG4-RD response rate between two groups at 24 weeks.
Timeline
- Start
- 2023-04-01
- Primary completion
- 2026-06-03
- Completion
- 2026-06-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tofacitinib | Small molecule | 5 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |