An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS
- Conditions
- The ANCA associated vasculitides (AASV), namely Wegener’s granulomatosis, microscopic polyangiitis, and renal limited vasculitis.
- Registration Number
- EUCTR2005-003610-15-CZ
- Lead Sponsor
- Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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 by ELISA or a typical cANCA pattern by indirect immunofluorescence (IIF), or both.
(b) MPO-ANCA by ELISA. A positive pANCA by IIF requires confirmation by MPO-ANCA ELISA.
4Written 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
1.Previous cyclophosphamide, (greater than 2 weeks of an oral or 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 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
- Primary Outcome Measures
Name Time Method Main Objective: To assess the rates of preliminary response and sustained remission of AASV following rituximab (on the basis of former studies, 86% sustained remission expected with rituximab compared to 75% in control group).<br>;Secondary Objective: To assess safety of a rituximab regimen in terms of severe adverse events (in patients receiving standard therapies, adverse advent rate is 45% at 2 years, at least 50% of which are infection relapted. In comparison rituximab use is only rarely associated with infections, therefore 22.5% adverse event rate expected with rituximab compared to 45% at 2 years in control group).<br>;Primary end point(s): Primary end points will be assessed upon trial completion at 2 years. <br>However interim analyses will be performed when <br>130 patients have completed 6 weeks, to assess efficacy (treatment response) and safety (severe adverse events).<br>240 patients have completed 6 months to assess efficacy (remission rates) and safety (severe adverse events).<br>
- Secondary Outcome Measures
Name Time Method