drugset / Trial / NCT00287079

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

NCT00287079

Parallel-groupOpen-labelTreatment

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

Timeline

Start
2005-10
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon beta-1a Protein / enzyme biologic 44 ug Subcutaneous

Indications

No indication recorded.