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

NCT00287079 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-12-27

Study results available
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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

DRUG

Rebif®

44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks

OTHER

No Treatment

No treatment for 96 weeks

Sponsors & Collaborators

  • EMD Serono Canada Inc.

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Director · EMD Serono Canada Inc.

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Canada

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00287079 on ClinicalTrials.gov