Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00468208
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2007-04-30
Brief Title:
Abatacept in Treating Adults With Mild Relapsing Wegeners Granulomatosis
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Multi-Center Open-label Pilot Study of Abatacept CTLA4-Ig in the Treatment of Mild Relapsing Wegeners Granulomatosis
Status:
COMPLETED
Status Verified Date:
2015-12
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:
Wegeners granulomatosis WG is a rare disease that causes inflammation of blood vessels or vasculitis It may involve many different parts of the body but typically affects the upper and lower respiratory tract and kidneys The purpose of this study is to determine the safety and effectiveness of the medication abatacept in treating adults with mild relapsing WG
Detailed Description:
Current standard treatment for WG involves various medications and is based on disease severity Unfortunately more than 50 of people experience a relapse after remission placing them at risk for additional organ damage and medication toxicity To prevent this safer and more effective treatments for mild relapses are needed Several studies have shown that activated T cells a type of white blood cell important in regulating immune responses play a role in WG Abatacept an immunoglobulin-based medication approved by the FDA to treat rheumatoid arthritis acts by preventing T-cell activation and may be useful in treating mild relapses of WG The purpose of this study is to determine the safety and effectiveness of abatacept in treating adults with mild relapsing WG
Participants will receive abatacept intravenously at study visits on Days 1 15 and 29 and then once a month thereafter A participants abatacept dose is based on body weight and will remain the same throughout the study Participants who are receiving maintenance immunosuppressive medications consisting of methotrexate azathioprine or mycophenolate mofetil at the time of enrollment will remain on these medications without dosage increase or reduction Eligible participants may be on up to prednisone 15mg daily at the time of relapse Following the development of relapse participants may be treated with up to prednisone 30mg daily if necessary but must to be back to the same dose that they had been on prior to relapse by Month 2 All study visits include medication review physical exam blood and urine collection and questionnaires A chest x-ray computed tomography CT scan of the chest and sinuses and lung function testing will occur at some study visits Participants whose symptoms did not improved by Month 2 will be taken off abatacept Any participants undergoing early termination or after common closing will undergo three follow-up study visits at 1 3 and 6 months after the end of treatment
Participants will receive abatacept intravenously at study visits on Days 1 15 and 29 and then once a month thereafter A participants abatacept dose is based on body weight and will remain the same throughout the study Participants who are receiving maintenance immunosuppressive medications consisting of methotrexate azathioprine or mycophenolate mofetil at the time of enrollment will remain on these medications without dosage increase or reduction Eligible participants may be on up to prednisone 15mg daily at the time of relapse Following the development of relapse participants may be treated with up to prednisone 30mg daily if necessary but must to be back to the same dose that they had been on prior to relapse by Month 2 All study visits include medication review physical exam blood and urine collection and questionnaires A chest x-ray computed tomography CT scan of the chest and sinuses and lung function testing will occur at some study visits Participants whose symptoms did not improved by Month 2 will be taken off abatacept Any participants undergoing early termination or after common closing will undergo three follow-up study visits at 1 3 and 6 months after the end of treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54AR057319 | NIH | None | httpsreporternihgovquickSearchU54AR057319 |