Overview
IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
Status:
Terminated
Terminated
Trial end date:
2009-08-01
2009-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses. HYPOTHESIS : MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing by 50% relapse rate, with a same frequency of adverse effectsPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Assistance Publique - Hôpitaux de ParisTreatments:
Azathioprine
Cyclophosphamide
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Criteria
Inclusion Criteria:- Newly diagnosed patients with WG, MPA or renal-limited vasculitis.
- ANCA positivity. ANCA positivity requires PR3-ANCA or a typical cANCA pattern by
indirect immunofluorescence (IIF), preferably confirmed by anti-PR3 ELISA. MPO-ANCA
determined by ELISA requires demonstration of pANCA, and pANCA by IIF requires
confirmation by anti-MPO ELISA. Optionally, central review of ANCA serology can be
performed.
- Age 18 to 75 years
Exclusion Criteria:
- Any cytotoxic drug within previous year, unless started within one months of entry and
according to the protocol design
- Co-existence of another systemic autoimmune disease, e.g. SLE
- Hepatitis B or Hepatitis C infection
- HIV positivity
- Failure to achieve remission after 6 months of CYC therapy
- Failure to control progressive disease with induction protocol
- Malignancy (usually exclude unless agreed with trial co-ordinator)
- Pregnancy or inadequate contraception
- Age below 18 and above 75 years*
- Endstage renal failure unless active extrarenal disease requires treatment (temporal
dependency of hemodialysis is not an exclusion criterion)
- Inability for informed consent
- After discussion with the trial administrator, patients less than 18 years may be
incorporated on separate application according to the appropriate local ethic
committee.