Clinical Trial: Prevention of Relapses in Proteinase 3 (PR3)-Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prevention of Relapses in PR3-ANCA-associated Vasculitis, a Tailored Approach
Brief 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).
Detailed 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 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).
Sponsor: University Medical Center Groningen
Current Primary Outcome: disease free survival [ Time Frame: four years after diagnosis ]
Original Primary Outcome: disease-free survival 4 years after diagnosis
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- cumulative organ damage
- side-effects
- cumulative dosages of cyclophosphamide, prednisolone and azathioprine
- quality of life
Information By: University Medical Center Groningen
Dates:
Date Received: August 9, 2005
Date Started: June 2003
Date Completion: December 2014
Last Updated: December 31, 2014
Last Verified: December 2014
