drugset / Trial / NCT03303989

REduCing Immunogenicity to PegloticasE (RECIPE) Study

NCT03303989

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

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 1000 mg
Comparator Pegloticase Protein / enzyme biologic 8 mg Intravenous

Indications