A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC
- Conditions
- Anti neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Wegener´s granulomatosis (WG) and microscopic polyangiitis (MPA) are primary systemic vasculitides associated with ANCA
- Registration Number
- EUCTR2006-001663-33-SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 140
- New diagnosis of AASV (WG or MPA) (within the previous 6 months)
- Active disease (defined by at least one major or three minor BVAS 2003 items (criteria listed in appendix 1 in the protocol)
- ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (as defined in appendix 1 in the protocol)
- Written informed consent
As specified in amendment no. 1, Sweden:
- only adult patients older than 18 years will be recruited
- women can be recruited only if they have a negative pregnancy test (pregnancy test will be performed during the 1st visit)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Previous treatment with:
1. MMF: more than two doses ever
2. Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of IV CYC (15mg/kg)
3. Rituximab or high dose intravenous immunoglobulin within the last twelve months
- Active infection (including hepatitis B, C, HIV and tuberculosis)
- Known hypersensitivity to MMF, AZA or CYC
- Cancer or an individual history of cancer (other than resected basal cell skin carcinoma)
- Females who are pregnant, breat feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
- Any condition judged by the investigator that would cause the study to be detrimental to the patient
- Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulianemia
- Active serious digestive system disease (e.g. inflammatory bowel disease)
- Patients with imminently life threatening vasculitis (diffuse alveolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis)
- Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated GFR fall >20% in previous two weeks
- GFR < 15mls/min at entry or on dialysis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method