Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588818
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2020-10-09
Brief Title:
Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
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:
The aim of this study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis
Detailed Description:
Although non-infectious uveitis is rare in pediatric population the irreversible visual impairment due to ocular complications severe drug adverse effects are disturbing There is a high rate of chronic disorder of ocular inflammation and unresponsiveness of therapy drugs in pediatric uveitis which result in structure destruction and functional impairment including band keratopathy posterior synechiae cataract and so on The systemic and topical glucocorticoid are advocated to control inflammation but carry a high risk of lots of advert events
Methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis it was benefit to prolong remission and reduce recurrence However despite early intervention 27-48 children do not achieve control of inflammation and 20 experience adverse events Adalimumab a fully human anti-tumor necrosis factor α monoclonal antibody is effective in the treatment of many rheumatic diseases ADA as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis a better visual acuity and a lower dose of dosage of daily glucocorticoid
The investigators propose to test the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year
Methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis it was benefit to prolong remission and reduce recurrence However despite early intervention 27-48 children do not achieve control of inflammation and 20 experience adverse events Adalimumab a fully human anti-tumor necrosis factor α monoclonal antibody is effective in the treatment of many rheumatic diseases ADA as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis a better visual acuity and a lower dose of dosage of daily glucocorticoid
The investigators propose to test the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year
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