Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03098225
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-15
First Post:
2017-03-21
Brief Title:
A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves Orbitopathy
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
Official Title:
A Phase IV Randomized Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves Orbitopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
ORGO
Brief Summary:
Graves orbitopathy GO is a disfiguring and disabling disease that profoundly impairs the quality of life of affected patients High dose intravenous iv glucocorticoids GC ivGC is a well established widely used treatment for active GO The use of systemic glucocorticoids takes advantage from their immune suppressive and antiinflammatory actions resulting in an overall beneficial effect ranging from 35 to 60 of patients in various studies The intravenous route of administration has been shown to be superior to the oral route both in terms of GO outcome and side effect profile The combination of ivGC and orbital radiotherapy OR is used routinely in patients with moderate-severe active GO as a second-line treatment as also recommended in the recent Guidelines published by the European Thyroid AssociationEuropean Group on Graves Orbitopathy Thus the majority of studies have shown that OR increases the response rate to GC Those studies were performed using oral GC whereas it is not known whether OR potentiate also the effects of ivGC
The present study is aimed at determining whether OR potentiate the effects of ivGC in the treatment of moderately severe and active GO in terms of GO outcome and quality of life A possible extension of the study can be foreseen aimed at investigating the very long time GO outcome
The present study is aimed at determining whether OR potentiate the effects of ivGC in the treatment of moderately severe and active GO in terms of GO outcome and quality of life A possible extension of the study can be foreseen aimed at investigating the very long time GO outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None