A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
NCT ID: NCT00287079
Last Updated: 2013-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2005-10-31
2008-11-30
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Rebif®
Rebif®
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
No Treatment
No Treatment
No treatment for 96 weeks
Interventions
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Rebif®
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
No Treatment
No treatment for 96 weeks
Eligibility Criteria
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Inclusion Criteria
* Subject must present with an abnormal MRI displaying at least 3 T2 weighted hyperintense lesions typical of multiple sclerosis (MS)
* Subject must be greater than or equal to 18 years old
* Subject must have had onset of the clinical attack within the last 120 days
* Subject must give written informed consent
* Female subjects must be neither pregnant nor breast feeding, and must not be of child-bearing potential as defined by either:
* Being post-menopausal or surgically sterile
* Using hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study
Subjects electing treatment:
* Subject must be eligible for Interferon-beta 1-a therapy
Exclusion Criteria
* Subject is pregnant or in lactation
* Subject suffers from an intercurrent autoimmune disease
* Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the procedures required by this study
* Subject has received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, campath), within 12 months of study day 1
Subjects electing treatment:
* Subject has inadequate liver function, defined by total bilirubin, aspartate transaminase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \> 2.5 times the upper limit of normal values
* Subject has inadequate bone marrow reserve, defined as white blood cell count less than 0.5 times the lower limit of normal
* Subject has a known allergy to IFN or any of the excipients of the drug product
18 Months
65 Years
ALL
No
Sponsors
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EMD Serono Canada Inc.
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
EMD Serono Canada Inc.
Locations
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Canadian Medical Information Office
Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada
Countries
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Related Links
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Full FDA approved prescribing information can be found here
Other Identifiers
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IMP 26222
Identifier Type: -
Identifier Source: org_study_id