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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00307645
• Date of registration: 27/03/2006
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
• Scientific title: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
• Date of first enrolment: May 2003
• Target sample size: 160
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00307645
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France, United Kingdom

Contacts

• Name: Loïc GUILLEVIN, MD,PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Granulomatosis and Microscopic Polyangiitis and

ANCA Associated Systemic Vasculitis Including Wegener’s

Renal Limited Vasculitis

Intervention(s)

Drug: Mycophenolate mofetil

Drug: Cyclophosphamide

Drug: Azathioprine

Drug: Prednisone (and methylprednisolone)

Primary Outcome(s)

or the end of the protocol (at 48 months)

the disease-free period, defined as the time between the beginning

of the maintenance therapy (AZA or MMF) and the first relapse (minor or major)

Secondary Outcome(s)

relapse rate

AUC for BVAS, SF-36 or VDI

cumulative doses (AZA, CS, MMF)

rate of side-effects and intolerance

Evolution of titers of ANCA and CRP

Secondary ID(s)

P991003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors