A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome (CIS-ON)
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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates [ Time Frame: Up to Week 96 ] [ Designated as safety issue: No ]CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.
- Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS) [ Time Frame: Up to Week 96 ] [ Designated as safety issue: Yes ]CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.
- Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to Week 96 ] [ Designated as safety issue: Yes ]AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.
|Study Start Date:||October 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
Other: No Treatment
No treatment for 96 weeks
|Canadian Medical Information Office|
|Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada|
|Study Director:||Medical Director||EMD Serono Canada Inc.|