Anti neutrophil cytoplasmic antibody (ANCA) associated vasculitis
Conditions
Interventions
Product Name: cyclophosphamide
Product Code: 5009111000001105
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: cyclophosphamide
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion (requires all) i) New diagnosis of AASV (WG or MPA) (within the previous six months) ii) Active disease (defined by at least one major or three minor BVAS 2003 items, see appendix 1) iii) ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (see appendix ) iv) Written informed consent Are the trial subjects under 18? yes 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
Exclusion criteria
Exclusion criteria: Exclusion i) Previous treatment with: (1) MMF: more than two weeks 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 ii) Active infection (including hepatitis B, C, HIV and tuberculosis). iii) Known hypersensitivity to MMF, AZA or CYC. iv) Cancer or an individual history of cancer (other than resected basal cell skin carcinoma). v) Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. vi) Any condition judged by the investigator that would cause the study to be detrimental to the patient. vii) Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulinaemia. viii) Active serious digestive system disease (e.g. inflammatory bowel disease) ix) Patients with imminently life threatening vasculitis (diffuse aleolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis). x) Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated GFR fall >20% in previous two weeks. xi) GFR <15mls/min at entry or on dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether a mycophenolate mofetil based regimen is equivalant in efficacy compared to a standard cyclophosphamide/azathioprine based treatment regimen for ANCA associated vasculitis.;Secondary Objective: To ascertain if adverse events, organ damage scores, adverse events, overall disease activity, cumulative immunosupression and steroid dosing and quality of life is better with myfortic compared to standard therapies.; Primary end point(s): Proportion of patients achieving remission by 6 months. (Remission is defined as the absence of disease activity attributable to active vasculitis BVAS =0 on two occasions at least one month apart and adherence to prednisolone taper. Patients in remission require low dose immunosupression and oral prednisolone to continue in order to maintain remission). | — |
Countries
Austria, Czech Republic, France, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed