Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128895
Status:
TERMINATED
Last Update Posted:
2018-12-13
First Post:
2005-08-09
Brief Title:
Prevention of Relapses in Proteinase 3 PR3-Anti-neutrophil Cytoplasmic Antibodies ANCA-Associated Vasculitis
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Prevention of Relapses in PR3-ANCA-associated Vasculitis a Tailored Approach
Status:
TERMINATED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 15512269-73 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
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 15512269-73 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None