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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by J.S.F. Sanders, University Medical Centre Groningen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00128895
First Posted: August 10, 2005
Last Update Posted: January 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Centre Groningen
  Purpose

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).


Condition Intervention Phase
Vasculitis Drug: azathioprine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Relapses in PR3-ANCA-associated Vasculitis, a Tailored Approach

Resource links provided by NLM:


Further study details as provided by J.S.F. Sanders, University Medical Centre Groningen:

Primary Outcome Measures:
  • disease free survival [ Time Frame: four years after diagnosis ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: June 2003
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: azathioprine, standard
standard azathioprine maintenance upto one year after diagnosis, subsequently tapering of azathioprine with 25 mg per 3 months
Drug: azathioprine
azathioprine 2 mg/kg oral once daily, duration according to arm
Experimental: azathioprine, longterm
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

Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128895


Locations
Netherlands
VU University Medical Centre
Amsterdam, Netherlands, 1081HV
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Martini Hospital Groningen
Groningen, Netherlands, 9700RM
Medical Centre Leeuwarden
Leeuwarden, Netherlands, 8901BR
University Hospital Maastricht
Maastricht, Netherlands, 6229 HX
UMC St Radboud
Nijmegen, Netherlands, 6525GC
Erasmus Medical Centre
Rotterdam, Netherlands, 3000CA
University Medical Centre Utrecht
Utrecht, Netherlands, 3508GA
Sponsors and Collaborators
University Medical Center Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Arthritis Association
Dutch Kidney Foundation
Investigators
Principal Investigator: Coen A Stegeman, MD, PhD University Medical Center Groningen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J.S.F. Sanders, dr JSF Sanders, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00128895     History of Changes
Other Study ID Numbers: AZA-ANCA-1
First Submitted: August 9, 2005
First Posted: August 10, 2005
Last Update Posted: January 23, 2015
Last Verified: December 2014

Keywords provided by J.S.F. Sanders, University Medical Centre Groningen:
Wegener's granulomatosis, ANCA, vasculitis, proteinase 3
ANCA-associated vasculitis
ANCA

Additional relevant MeSH terms:
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Azathioprine
Antibodies, Antineutrophil Cytoplasmic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents