An International, randomised, open trial comapring a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of 'generalised' ANCA associated vasculitis. - RITUXVAS

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

• Registration Number: EUCTR2005-003610-15-SE
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-29
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

(all four must be present)
1.A new diagnosis of WG, MP or renal-limited vasculitis (RLV)(appendix 1)
2.Renal involvement attributable to active WG, MP or RLV with at least one of the following:
a)biopsy demonstrating necrotizing glomerulonephritis.
b)red cell casts on urine microscopy or = ++ haematuria
3.ANCA positivity ANCA positivity requires either (a) or (b)
(a) PR3-ANCA or a typical cANCA pattern by indirect immunofluorescence (IIF), preferably confirmed by anti-PR3 ELISA.
(b) MPO-ANCA determined by ELISA requires demonstration of pANCA, and pANCA by IIF requires confirmation by anti-MPO ELISA .
4. 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

1.Previous cyclophosphamide, greater than 2 weeks of oral or one IV pulse = 15mg/kg cyclophosphamide
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 e 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.
7Allergy to a study medication
8Live Vaccine within last 4 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified