Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Aspreva Pharmaceuticals; Vifor Pharma
• Treatments: Cyclophosphamide; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

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 Criteria:

• 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.