A randomised clinical trial of mycophenolat mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC

Phase 1

• Conditions: Anti neutrophil cytoplasmic antibody (ANCA) associated vasculitis

• Registration Number: EUCTR2006-001663-33-AT
• Lead Sponsor: Vasculitis Clinical Trial Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-02
• Study Completion: 2013-02-14
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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? 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

Exclusion Criteria

v) previous treatment with
(1) MMF: more than two weeks ever
(2) Cyclophosphamide: more than two weeks daily oral or more than one pulse of IV CYC ( 15mg/kg)
(3) Rituximab or high dose intravenous immunoglobulin within the last twelve months
vi) active infection (including hepatitis B, C, HIV and tuberculosis)
vii) known hypersensitivity to MMF, AZA or CYC
viii) Cancer or an individual history of cancer ( other than resected basal cell skin carcinoma)
ix) Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
x) Any condition judged by the investigator that would cause the study to be detrimental to the patient
xi) Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulinaemia
xii) Active serious digestive system disease ( e.g. inflammatory bowel disease)
xiii) Patients with imminently life threatening vasculitis (diffuse alveolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis).
xiv) Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated GFR fall > 20% in previous two weeks.
xv) GFR<15 mls/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
Primary end point(s): Proportion of patients archieving 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 immunosuppression and oral prednisolone to continue in order to maintain remission).;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, overall disease activity, cumulative immunosupression and steroid dosing and quality of life is better with mycophenolate mofetil compared to standard therapies.