Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03209219
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2017-07-04
Brief Title:
Interferon α2a Versus Cyclosporine for Refractory Behçets Disease Uveitis
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçets Disease Uveitis
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Brief summary This study compares the long-term efficacy and safety of interferon IFN α2a and cyclosporine cyclosporin A CsA following suppression of acute attack by high-dose oral glucocorticosteroid in patients with refractory Behçets uveitis BDU Half of the participants will receive IFNα2a while the other half will receive CsA
Detailed Description:
Detailed description Both CsA and IFNα2a have been shown to be effective for long-term control of BDU however randomized prospective comparative studies are scarce particularly in East Asian populations Our preliminary data gave us the impression that IFNα2a might be more effectiveness than CsA in long-term control of refractory BDU and this study aimed to compare their effectiveness and safety profiles in a well-designed prospective study Refractory BDU is defined as relapse of posterior or pan- uveitis with at least 10mg daily prednisone or equivalent and one traditional immunomodulatory treatment IMT agents The acute attack is controlled with large dose oral corticosteroid 60mg daily prednisone for 4 weeks and then the patients are randomly assigned to the IFN arm and the CsA arm in which patients are treated with IFNα2a 3106 IU qd for 4 weeks and qod thereafter and CsA 100mg bid respectively along with a fixed tapering regimen of corticosteroid Patients were followed up until relapse or for 12 months
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