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 Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
35
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
No treatment for 96 weeks
Canadian Medical Information Office
Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada
Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
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.
Time frame: Up to Week 96
Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)
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.
Time frame: Up to Week 96
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
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.
Time frame: Up to Week 96
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