Prevention of Relapses in Proteinase 3 (PR3)-Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis
Status:
Terminated
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Treatment of patients with PR3-ANCA-associated vasculitis consists of two phases: remission
induction with highly effective, but also relatively toxic, drugs and, secondly, after
remission is achieved, maintenance therapy with less toxic drugs. Currently,
remission-maintenance therapy with azathioprine is stopped after approximately 18 months.
However, the optimal duration of azathioprine maintenance therapy is unknown.
The investigators have found that patients with PR3-ANCA-associated vasculitis who remain
cytoplasmic anti-neutrophil cytoplasmic autoantibody (C-ANCA) positive after induction of
remission have an increased risk to experience relapse of disease. Therefore they will test
whether relapse risk in these patients can be reduced by extending maintenance therapy at the
cost of acceptable therapy related toxicity. After induction of stable remission, ANCA will
be measured by immunofluorescence (IIF). C-ANCA positive patients will be randomized for
either standard therapy with azathioprine (until 18 months after diagnosis), or longterm
azathioprine maintenance therapy (until 48 months after diagnosis).
Phase:
Phase 4
Details
Lead Sponsor:
University Medical Center Groningen
Collaborators:
Dutch Arthritis Association Dutch Kidney Foundation ZonMw: The Netherlands Organisation for Health Research and Development