drugset / Trial / NCT03303989
REduCing Immunogenicity to PegloticasE (RECIPE) Study
RandomizedParallel-groupDouble-blindTreatment
Summary
Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life.
Timeline
- Start
- 2018-06-14
- Primary completion
- 2020-04-27
- Completion
- 2021-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 1000 mg | — |
| Comparator | Pegloticase | Protein / enzyme biologic | 8 mg | Intravenous |