A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
Condition: Clinically Isolated Syndrome
MeSH terms: Syndrome
Intervention: Rebif®; No Treatment
Intervention description: 44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks; No treatment for 96 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Months
Maximum age: 65 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have experienced a first clinical episode suggestive of demyelinating
             disease

          -  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 has evidence of other neurological diseases that could explain his/her
             symptomatology

          -  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