Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 4:33 AM
Study NCT ID:
NCT00101959
Status:
WITHDRAWN
Last Update Posted:
2013-08-06
First Post:
2005-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) Subjects
Sponsor:
EMD Serono
Organization:
Study Overview
Official Title:
An Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy
Status:
WITHDRAWN
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brief Summary: 800 RRMS Subjects currently treated with Avonex or Copaxone will be randomized to either continue on their current therapy or receive Rebif therapy. The subjects will be followed for 2 years. The primary objective is to compare the time to worsening to a medium level of concern as defined by the Canadian Multiple Sclerosis Working Group (CMSWG) treatment optimization recommendations.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: