Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424151
Status:
COMPLETED
Last Update Posted:
2010-10-06
First Post:
2007-01-17
Brief Title:
Rituximab Treatment of Graves Dysthyroid Ophthalmopathy
Sponsor:
Silkiss Rona Z MD FACS
Organization:
Silkiss Rona Z MD FACS
Study Overview
Official Title:
Rituximab Treatment of Graves Dysthyroid Ophthalmopathy Phase III
Status:
COMPLETED
Status Verified Date:
2010-10
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:
This study is designed to treat patients with Graves disease with Rituximab in an attempt to prevent or reverse the physically deforming and debilitating consequences of this disease
Detailed Description:
Graves Dysthyroid ophthalmopathy is an autoimmune disease characterized by inflammatory changes of the periocular and orbital region often in association with an underlying thyroid abnormality These changes can be extremely debilitating and may lead to visual loss Attempts at limiting or reversing the phenotypic expression of Graves ophthalmopathy through aggressive orbital decompression surgery or targeting the inflammatory disease using high dose systemic corticosteroids andor orbital radiotherapy have been limited to date by treatment ineffectiveness and co-morbidities Selective B-cell depletion therapy offers a potential treatment alternative This study is designed to treat patients with Graves disease with Rituximab in an attempt to prevent or reverse the physically deforming and debilitating consequences of this disease
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