Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390436
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-25
Brief Title:
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis an Open-label Non-inferiority Randomised Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
SMOOTH
Brief Summary:
Uveitis and its complications are thought to account for 10 to 15 of preventable blindness in Western countries The diagnosis of chronic non-infectious uveitis CNUI can be made after exclusion of pseudo uveitis or infectious uveitis in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment Adalimumab ADA an anti-TNFα monoclonal antibody has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids The use of ADA has been optimized in particular through Therapeutic Drug Monitoring TDM based on the determination of serum ADA levels and anti-ADA antibodies Recently an article showed that a strategy of spacing ADA administrations in RA patients with concentrations 8 μgmL was not inferior to standard
Detailed Description:
There is currently no formal recommendation for spacing ADA administration in patients with chronic noninfectious uveitis but promising data from a recent retrospective study conducted by the Croix-Rousse team led to the proposal of a decision support algorithm Following the example of what has been shown in rheumatoid arthritis the investigators propose to compare a strategy of spacing ADA administrations in patients with a satisfactory clinical response associated with high serum ADA concentrations
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509733-39-00 | OTHER | CTIS | None |