At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Rebif® and No Treatment for Clinically Isolated Syndrome. Completed, enrolled 35 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
No treatment for 96 weeks