IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
ANCA Associated Systemic Vasculitis Including Wegener's, Granulomatosis and Microscopic Polyangiitis and, Renal Limited Vasculitis
About this trial
This is an interventional treatment trial for ANCA Associated Systemic Vasculitis Including Wegener's focused on measuring ANCA associated systemic vasculitis, Maintenance therapy, Azathioprine, Mycophenolate mofetil
Eligibility 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.
Sites / Locations
- Hopital Cochin
- Addenbrooke's Hospital - Departement of Medecine