Status:
TERMINATED
IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
ANCA Associated Systemic Vasculitis Including Wegener's
Granulomatosis and Microscopic Polyangiitis and
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 relaps...
Detailed Description
AASV, including Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA) and renal limited vasculitis (RLV), are progressive, multisystem, autoimmune diseases which require the prescription of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00307645
Start Date
May 1 2003
End Date
August 1 2009
Last Update
April 10 2006
Active Locations (2)
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1
Hopital Cochin
Paris, France, 75679
2
Addenbrooke's Hospital - Departement of Medecine
Cambridge, United Kingdom, CB2 2SP