Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01261169
Status:
UNKNOWN
Last Update Posted:
2010-12-16
First Post:
2010-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mycophenolate Sodium (Myfortic®) in the Treatment of Corticosteroid-refractory Autoimmune Uveitis:Pilot Study
Sponsor:
Genovate Biotechnology Co., Ltd.,
Organization:
Study Overview
Official Title:
Mycophenolate Sodium (Myfortic®) in the Treatment of Corticosteroid-refractory Autoimmune Uveitis:Pilot Study
Status:
UNKNOWN
Status Verified Date:
2010-12
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:
This study is designed to explore the use of Myfortic® in patients with steroid-refractory uveitis. The aim of the study will be to show the therapeutic effect of Myfortic® in managing uveitis patients.
Detailed Description:
This study is a single arm prospective evaluation in which patients with uveitis are treated with Myfortic® in a dose of 360 mg bid for six months. From day 0, Myfortic will be combined with 1 mg/kg prednisone. Prednisone will be tapered from week 1 based on the clinical findings of the ophthalmologist.
There will be no other stratification of patients. After the screening, patients will be treated with Myfortic® for 6 months. Patients will be seen at month 1, 3, and 6. Thereafter patients will be followed up at month 12. Efficacy and safety assessments will be performed at each visit.
There will be no other stratification of patients. After the screening, patients will be treated with Myfortic® for 6 months. Patients will be seen at month 1, 3, and 6. Thereafter patients will be followed up at month 12. Efficacy and safety assessments will be performed at each visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: