Who is sponsoring NCT00103792?

NCT00103792 is sponsored by University Medical Center Groningen.

What condition does NCT00103792 study?

NCT00103792 studies Wegener's Granulomatosis, Vasculitis.

What drugs are being tested in NCT00103792?

Interventions: mycophenolate mofetil, cyclophosphamide.

What is the status of NCT00103792?

NCT00103792 is currently COMPLETED.

Last reviewed 2024-08-23 · How we verify

Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-life-threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis

NCT00103792 Phase 3 COMPLETED

The purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil. The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.

Details

Lead sponsor	University Medical Center Groningen
Phase	Phase 3
Status	COMPLETED
Enrolment	84
Start date	2004-12
Completion	2015-01

Conditions

Wegener's Granulomatosis
Vasculitis

Interventions

mycophenolate mofetil
cyclophosphamide

Primary outcomes

remission induction rate — 6 months
disease free survival after 2 and 4 years — 2 and 4 years

Countries

Netherlands