Overview

IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis

Status:
Terminated
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
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 effects
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
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.