Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185211
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2005-09-09
Brief Title:
BENEFIT Study Betaferon Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment and BENEFIT Follow-up Study
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Open-label Multi-center Phase III Extension of the Double-blind Placebo-controlled BENEFIT Study no 92012304747 to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis MS and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU 250 µg Interferon Beta-1b Betaferon Betaseron Given Subcutaneously Every Other Day for at Least 36 Months
Status:
COMPLETED
Status Verified Date:
2013-12
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 study will primarily compare the long-term effects of an early and continued treatment with BetaferonBetaseron patients who were treated with active medication during the double-blind BENEFIT study to treatment initiated either after Clinically Definite Multiple Sclerosis CDMS has been diagnosed or after two years those patients who were treated with placebo during the double-blind BENEFIT study
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study
Detailed Description:
The study has previously been posted by Schering AG Germany Schering AG Germany has been renamed to Bayer HealthCare Pharmaceuticals Inc
Bayer HealthCare Pharmaceuticals Inc is the sponsor of the trial
Bayer HealthCare Pharmaceuticals Inc is the sponsor of the trial
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 |
|---|---|---|---|
| 305207 | OTHER | Company Internal | None |