Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258915
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-23
Brief Title:
Treatment FOr Corticosteroid Dependent UveitiS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Controlled Multicenter Study Comparing Efficacy and Safety of Adalimumab to That of Mycophenolate Mofetil in Steroid Dependent Non-infectious Uveitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
FOCUS
Brief Summary:
FOCUS is the first prospective randomized study comparing standard of care mycophenolate mofetil to adalimumab in recently active non infectious uveitis NIU with steroid dependency There is no firm evidence or randomized trials that compared classical immunosuppressive compounds to biological agents or identified the best treatment in this condition The burden of NIU has been reduced with the use of immunosuppressive agents and biologics raising the question of which of these compounds should be preferentially used in recently active NIU with steroid dependency
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?:
None
Is an FDA AA801 Violation?:
None