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Prevention of Relapses in Proteinase 3 (PR3)-Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis

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ClinicalTrials.gov Identifier: NCT00128895
Recruitment Status : Unknown
Verified December 2014 by J.S.F. Sanders, University Medical Center Groningen.
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2005
Last Update Posted : January 1, 2015
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Arthritis Association
Dutch Kidney Foundation
Information provided by (Responsible Party):
J.S.F. Sanders, University Medical Center Groningen

August 9, 2005
August 10, 2005
January 1, 2015
June 2003
June 2014   (Final data collection date for primary outcome measure)
disease free survival [ Time Frame: four years after diagnosis ]
disease-free survival 4 years after diagnosis
Complete list of historical versions of study NCT00128895 on ClinicalTrials.gov Archive Site
  • 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 ]
  • cumulative organ damage
  • side-effects
  • cumulative dosages of cyclophosphamide, prednisolone and azathioprine
  • quality of life
Not Provided
Not Provided
 
Prevention of Relapses in Proteinase 3 (PR3)-Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis
Prevention of Relapses in PR3-ANCA-associated Vasculitis, a Tailored Approach

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).

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Vasculitis
Drug: azathioprine
azathioprine 2 mg/kg oral once daily, duration according to arm
  • Active Comparator: azathioprine, standard
    standard azathioprine maintenance upto one year after diagnosis, subsequently tapering of azathioprine with 25 mg per 3 months
    Intervention: Drug: azathioprine
  • Experimental: azathioprine, longterm
    longterm maintenance with azathioprine upto four years after diagnosis, subsequently azathioprine will be tapered with 25 mg per 3 months
    Intervention: Drug: azathioprine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
180
Same as current
December 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed ANCA-associated vasculitis
  • PR3-ANCA antibodies present
  • Indication for treatment with cyclophosphamide and prednisolone

Exclusion Criteria:

  • Intolerance or allergy to azathioprine
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00128895
AZA-ANCA-1
No
Not Provided
Not Provided
J.S.F. Sanders, University Medical Center Groningen
University Medical Center Groningen
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Dutch Arthritis Association
  • Dutch Kidney Foundation
Principal Investigator: Coen A Stegeman, MD, PhD University Medical Center Groningen
University Medical Center Groningen
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP