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| Sponsors and Collaborators: |
University Medical Centre Groningen ZonMw: The Netherlands Organisation for Health Research and Development Dutch Arthritis Association Dutch Kidney Foundation |
|---|---|
| Information provided by: | University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT00128895 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Prevention of Relapses in PR3-ANCA-Associated Vasculitis, a Tailored Approach |
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Coen A Stegeman, MD, PhD | +31503616161 | c.a.stegeman@int.umcg.nl |
| Contact: Jan-Stephan F Sanders, MD | +31503616161 | j.sanders@int.umcg.nl |
| Netherlands | |
| University Medical Centre Groningen | Recruiting |
| Groningen, Netherlands, 9700 RB | |
| Contact: Coen A Stegeman, MD, PhD +31503616161 c.a.stegeman@int.umcg.nl | |
| Principal Investigator: Coen A Stegeman, MD, PhD | |
| Sub-Investigator: Jan-Stephan F Sanders, MD | |
| University Hospital Maastricht | Recruiting |
| Maastricht, Netherlands, 6229 HX | |
| Contact: JW Cohen Tervaert, MD, PhD +31-43-3876543 Jw.Cohentervaert@immuno.unimaas.nl | |
| Principal Investigator: JW Cohen Tervaert, MD, PhD | |
| Erasmus Medical Centre | Recruiting |
| Rotterdam, Netherlands, 3000CA | |
| Contact: P Van Daele, MD, PhD 31104639222 p.l.a.vandaele@erasmusmc.nl | |
| UMC St Radboud | Recruiting |
| Nijmegen, Netherlands, 6525GC | |
| Contact: R de Sevaux, MD, PhD 310243611111 r.desevaux@nier.umcn.nl | |
| VU University Medical Centre | Recruiting |
| Amsterdam, Netherlands, 1081HV | |
| Contact: A Voskuyl, MD, PhD 31204444444 ae.voskuyl@vumc.nl | |
| Martini Hospital Groningen | Recruiting |
| Groningen, Netherlands, 9700RM | |
| Contact: W D Kloppenburg, MD, PhD 31505245245 w.d.kloppenburg@mzh.nl | |
| University Medical Centre Utrecht | Recruiting |
| Utrecht, Netherlands, 3508GA | |
| Contact: R Hene, MD, PhD 31302509111 | |
| Medical Centre Leeuwarden | Recruiting |
| Leeuwarden, Netherlands, 8901BR | |
| Contact: J Broekroelofs, MD, PhD 31582866666 J.Broekroelofs@znb.nl | |
| Principal Investigator: | Coen A Stegeman, MD, PhD | University Medical Centre Groningen |
More Information
| Responsible Party: | University Medical Center Groningen ( dr. C.A. Stegeman ) |
| Study ID Numbers: | AZA-ANCA-1 |
| Study First Received: | August 9, 2005 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00128895 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Wegener's granulomatosis, ANCA, vasculitis, proteinase 3 ANCA-associated vasculitis ANCA |
|
Antibodies, Antineutrophil Cytoplasmic Antibodies Azathioprine Vasculitis |
Wegener Granulomatosis Wegener's granulomatosis Vascular Diseases Immunoglobulins |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |
