drugset / Trial / NCT05113004
New Clinical End-points in Patients With Primary Sjögren's Syndrome
RandomizedParallel-groupTriple-blindTreatment
Summary
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS. Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.
Timeline
- Start
- 2022-01-20
- Primary completion
- 2025-04-01
- Completion
- 2025-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 400 mg | — |
| Subject | Leflunomide | Small molecule | 20 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 2000 mg | — |