An international, randomised, open label trial comparing a rituximab-based regimen with a standard cyclophosphamide/azathioprine based regimen in the treatment of active, generalised anti-neutrophilic cytoplasmic antibodies associated vasculitis

Completed

• Conditions: ANCA associated vasculitis; Circulatory System

• Registration Number: ISRCTN28528813
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. A new diagnosis of Wegener's Granulomatosis (WG), Microscopic Polyangiitis (MP) or Renal-Limited Vasculitis (RLV)
2. Renal involvement attributable to active WG, MP or RLV with at least one of the following:
2.1. Biopsy demonstrating necrotizing glomerulonephritis
2.2. Red cell casts on urine microscopy or =++ haematuria
3. Anti-Neutrophilic Cytoplasmic Antibodies (ANCA) positivity; ANCA positivity requires either:
3.1. Proteinase 3 anti-neutrophilic cytoplasmic antibody (PR3-ANCA) by Enzyme-Linked Immunosorbent Assay (ELISA) or a typical antineutrophil cytoplasmic antibody (cANCA) pattern by indirect immunofluorescence (IIF), or both
3.2. Myeloperoxidase- anti-neutrophilic cytoplasmic antibody (MPO-ANCA) by ELISA. A positive perinuclear anti-neutrophilic cytoplasmic antibody (pANCA) by IIF requires confirmation by MPO-ANCA ELISA
4. Written informed consent

Exclusion Criteria

1. Previous cyclophosphamide, (greater than two weeks of an oral or intravenous [IV] pulse cyclophosphamide regimen)
2. Co-existence of another multisystem autoimmune disease, e.g. SLE, Churg Strauss syndrome, Henoch Schonlein purpura, rheumatoid vasculitis, essential mixed cryoglobulinaemia, anti-glomerular basement membrane antibody positivity
3. Hepatitis B antigen positive or hepatitis C antibody positive
4. Known HIV positive (HIV testing will not be a requirement for this trial)
5. Previous malignancy (usually exclude unless agreed with trial co-ordinator)
6. Pregnancy, breast feeding or inadequate contraception if female
7. Allergy to a study medication
8. Live vaccine within last four weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified