Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310837
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-02-20
Brief Title:
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis
Sponsor:
Zhongshan Ophthalmic Center Sun Yat-sen University
Organization:
Zhongshan Ophthalmic Center Sun Yat-sen University
Study Overview
Official Title:
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis A Multicenter Randomized Non-inferiority Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a multi-center prospective randomized controlled non-inferior clinical study A total of 120 subjects with non-infectious intermediate posterior or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers They were randomly assigned to the experimental group and the control group according to 1 1 We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents and there are no additional adverse events and safety issues
Detailed Description:
The study will be followed up in the screening-baseline period and at 4812182436 and 48 weeks after the start of the study drug The ETDRS letter number change of the best corrected visual acuity BCVA at 24 weeks compared with the baseline was used as the main indicator The last follow-up was performed at 48 weeks
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