Anti neutophil cytoplasmic antibody (ANCA) associated vasculitis
Conditions
Interventions
Trade Name: MabThera
Product Name: Rituximab
Product Code: Rituximab
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: ritu
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To ascertian whether a rituximab based treatment regimen is safer and more effective than a standard cyclophosphamide/azathioprine based treatment regimen for ANCA associated vasculitis.;Secondary Objective: To ascertain if organ damage scores, adverse events, overall disease activity, cumulative immunosupression and steroid dosing, and quality of life is better with rituximab compared to standard therapies. In addition, to monitor antibody formation associated with rituximab use.; Primary end point(s): 1 Sustained remission (BVAS = 0 at 6 months and sustained for 6 months). 2 Severe adverse events (CTCAE grade = 3) at 2 years. | — |
Countries
Czech Republic, Sweden, United Kingdom
Outcome results
None listed