Status:
COMPLETED
Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Aspreva Pharmaceuticals
Vifor Pharma
Conditions:
Vasculitis
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.
Detailed Description
There is a clear need for improved therapy in ANCA associated vasculitis where current treatments are toxic and contribute to poor outcomes. Conventional therapy combines cyclophosphamide with prednis...
Eligibility Criteria
Inclusion
- Inclusion (requires all):
- New diagnosis of AASV (WG or MPA) (within the previous six months)
- Active disease (defined by at least one major or three minor BVAS 2003 items, see appendix 1)
- ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (see appendix )
- Written informed consent
Exclusion
- Previous treatment with:
- MMF: more than two weeks ever.
- Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of IV CYC (15mg/kg)
- 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, breast 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 cryoglobulinaemia.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00414128
Start Date
March 1 2007
End Date
February 1 2013
Last Update
December 6 2013
Active Locations (1)
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1
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB22QQ