Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428584
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2007-01-29
Brief Title:
RNF and Betaseron Tolerability Study
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Randomized Multicenter Two Arm Open Label Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif New Formulation IFN Beta-1a and Betaseron IFN Beta-1b in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis RRMS Followed by a Single Arm Eighty-two Week Minimum Rebif New Formulation Only Safety Extension
Status:
COMPLETED
Status Verified Date:
2013-08
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:
REFORMS
Brief Summary:
To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis RRMS by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration
Detailed Description:
None
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