NCT00287079

A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Months – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Clinically Isolated Syndrome

Interventions

Type	Name	Description
DRUG	Rebif®	44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
OTHER	No Treatment	No treatment for 96 weeks

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2006-02-06
• Last updated: 2013-12-27
• Results posted: 2012-04-04

Locations

1 site across 1 country: Canada