drugset / Trial / NCT02703194
Leflunomide for Maintenance of Remission in IgG4 Related Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
The study has been designed as a 12-month, open-label, randomized, controlled study comparing the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in treating patients with IgG4-related disease.
Timeline
- Start
- 2016-03
- Primary completion
- 2019-01
- Completion
- 2019-01
Outcome
Met primary endpoint
paper The combination therapy was significantly superior to GCs monotherapy regarding the primary outcome, the time to relapse (HR, 0.35; 95% confidence interval [CI], 0.13-0.90; P = 0.023) PMID 32113839 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leflunomide | Small molecule | 20 mg | — |
| Background | Prednisone | Other / unclassified | 5 mg | — |