Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287079
Status:
COMPLETED
Last Update Posted:
2013-12-27
First Post:
2006-02-02
Brief Title:
A Prospective Study Looking at the Use of Rebif in Subjects With Clinically Isolated Syndrome
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Prospective Open Label Multi-centre Study Exploring the Use of Subcutaneous sc 44 Microgram Interferon IFN Beta - 1a Rebif Once a Week qw in Subjects With Clinically Isolated Syndrome CIS
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:
CIS-ON
Brief Summary:
The primary objective of this initiative is to assess the effectiveness of subcutaneous sc interferon IFN beta - 1a Rebif versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis CDMS - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome CIS accompanied by an abnormal magnetic resonance imaging MRI The secondary objectives are to
Assess the effectiveness of sc IFN beta - 1a Rebif therapy in reducing the proportion of patients with CIS converting to CDMS
Assess the safety of sc IFN beta - 1a Rebif in the patients with CIS
Assess the effectiveness of sc IFN beta - 1a Rebif therapy in reducing the proportion of patients with CIS converting to CDMS
Assess the safety of sc IFN beta - 1a Rebif in the patients with CIS
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