A Phase 4 interventional study of azathioprine in Vasculitis, sponsored by University Medical Center Groningen. Terminated at 8 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-13.
Sponsored by University Medical Center Groningen · Phase 4, Interventional, and Treatment
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).
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 C-ANCA positive after induction of remission have an increased risk to experience relapse of disease (MC Slot et al. Arthritis Rheum. 2004 15;51(2):269-73). 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 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).
230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.
This study's enrollment of 131 is above the median of 48 across 119 interventional studies indexed under Vasculitis.
Browse Vasculitis studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Exclusion Criteria:
standard azathioprine maintenance upto one year after diagnosis, subsequently tapering of azathioprine with 25 mg per 3 months
Drug: azathioprine
longterm maintenance with azathioprine upto four years after diagnosis, subsequently azathioprine will be tapered with 25 mg per 3 months
Drug: azathioprine
azathioprine 2 mg/kg oral once daily, duration according to arm
disease free survival
Time frame: four years after diagnosis
cumulative organ damage
Time frame: four years after diagnosis
side-effects
Time frame: up to four years after diagnosis
cumulative dosages of cyclophosphamide, prednisolone and azathioprine
Time frame: up to four years after diagnosis
quality of life
Time frame: four years after diagnosis
This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen