Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167583
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2005-09-09
Brief Title:
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcets Disease INCYTOB
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Phase III Study of Recombinant Human Interferon-alpha2a Versus Cyclosporin A for the Treatment of Ocular Behcets Disease - a NationalRandomised Single-masked Controlled Trial INCYTOB
Status:
COMPLETED
Status Verified Date:
2016-05
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:
INCYTOB
Brief Summary:
The purpose of this study is to investigate if interferon-alpha2a is superior to the standard treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcets disease
Detailed Description:
Behcets disease is a multisystem vasculitis often involving ocular retinal blood vessels in 70 of all cases This form of uveitis or retinal vasculitis still leads to blindness in 25 to 50 of the patients irrespective of immunosuppressive treatment
The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard treatment cyclosporin A CSA for severe ocular panuveitis posterior uveitis retinal vasculitis Behçets Disease BD and significantly improves visual prognosis and quality of health and life of the patients with ocular BD and is acting more rapidly than standard treatment Furthermore we want to evaluate if IFN-α induces long term remissions of ocular BD which can be maintained without further medical treatment
The patients are randomised into two treatment groups IFNCSA and treated for one year according to an algorithm which adapts dosages to clinical course A crossover from one treatment arm to the other is planned in case of inefficacy
The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard treatment cyclosporin A CSA for severe ocular panuveitis posterior uveitis retinal vasculitis Behçets Disease BD and significantly improves visual prognosis and quality of health and life of the patients with ocular BD and is acting more rapidly than standard treatment Furthermore we want to evaluate if IFN-α induces long term remissions of ocular BD which can be maintained without further medical treatment
The patients are randomised into two treatment groups IFNCSA and treated for one year according to an algorithm which adapts dosages to clinical course A crossover from one treatment arm to the other is planned in case of inefficacy
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMBF-01KG0706 | OTHER_GRANT | German Ministry of Health | None |