drugset

drugset / Trial / NCT00414128

Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

NCT00414128 ↗

Phase 2/3 Completed 140 enrolled Cambridge University Hospitals NHS Foundation Trust Aspreva Pharmaceuticals · collab Vifor Pharma · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.

Timeline

Start: 2007-03
Primary completion: 2011-07
Completion: 2013-02

Publications

Jones RB, Hiemstra TF, Ballarin J, Blockmans DE, Brogan P, Bruchfeld A, Cid MC, Dahlsveen K, de Zoysa J, Espigol-Frigole G, Lanyon P, Peh CA, Tesar V, Vaglio A, Walsh M, Walsh D, Walters G, Harper L, Jayne D; European Vasculitis Study Group (EUVAS). Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial. Ann Rheum Dis. 2019 Mar;78(3):399-405. doi: 10.1136/annrheumdis-2018-214245. Epub 2019 Jan 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclophosphamide	Other / unclassified	15 mg/kg	Intravenous
Subject	Mycophenolate Mofetil	Small molecule	2 g	—
Subject	Mycophenolate Mofetil	Small molecule	3 g	—

Indications