Prevention of Relapses in Proteinase 3 (PR3)-Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis
NCT ID: NCT00128895
Last Updated: 2018-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
131 participants
INTERVENTIONAL
2003-06-30
2014-12-31
Brief Summary
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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 Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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azathioprine, standard
standard azathioprine maintenance upto one year after diagnosis, subsequently tapering of azathioprine with 25 mg per 3 months
azathioprine
azathioprine 2 mg/kg oral once daily, duration according to arm
azathioprine, longterm
longterm maintenance with azathioprine upto four years after diagnosis, subsequently azathioprine will be tapered with 25 mg per 3 months
azathioprine
azathioprine 2 mg/kg oral once daily, duration according to arm
Interventions
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azathioprine
azathioprine 2 mg/kg oral once daily, duration according to arm
Eligibility Criteria
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Inclusion Criteria
* PR3-ANCA antibodies present
* Indication for treatment with cyclophosphamide and prednisolone
Exclusion Criteria
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Dutch Arthritis Association
INDUSTRY
Dutch Kidney Foundation
OTHER
University Medical Center Groningen
OTHER
Responsible Party
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J.S.F. Sanders
dr JSF Sanders
Principal Investigators
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Coen A Stegeman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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VU University Medical Centre
Amsterdam, , Netherlands
University Medical Centre Groningen
Groningen, , Netherlands
Martini Hospital Groningen
Groningen, , Netherlands
Medical Centre Leeuwarden
Leeuwarden, , Netherlands
University Hospital Maastricht
Maastricht, , Netherlands
UMC St Radboud
Nijmegen, , Netherlands
Erasmus Medical Centre
Rotterdam, , Netherlands
University Medical Centre Utrecht
Utrecht, , Netherlands
Countries
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References
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Sanders JS, de Joode AA, DeSevaux RG, Broekroelofs J, Voskuyl AE, van Paassen P, Kallenberg CG, Tervaert JW, Stegeman CA. Extended versus standard azathioprine maintenance therapy in newly diagnosed proteinase-3 anti-neutrophil cytoplasmic antibody-associated vasculitis patients who remain cytoplasmic anti-neutrophil cytoplasmic antibody-positive after induction of remission: a randomized clinical trial. Nephrol Dial Transplant. 2016 Sep;31(9):1453-9. doi: 10.1093/ndt/gfw211. Epub 2016 May 30.
Other Identifiers
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AZA-ANCA-1
Identifier Type: -
Identifier Source: org_study_id