Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Interferon-beta-1a FBS-free/HSA-free
Intervention description: Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing forms of multiple sclerosis

Summary:

      The primary objective of the study is to compare the immunogenicity of the new fetal bovine
      serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a relapsing form of Multiple Sclerosis (MS); diagnosis of MS is in
             accordance with the McDonald criteria

          -  Participant is eligible for interferon therapy

          -  Participant is between 18 and 60 years old

          -  Participant has an Expanded Disability Status Scale (EDSS) < 6.0.

          -  Participant is willing to follow study procedures

          -  Participant has given written informed consent

          -  Female participants must be neither pregnant nor breast-feeding, and must lack
             childbearing potential, as defined by either:

          -  Being post-menopausal or surgically sterile, or

          -  Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or
             condom with spermicide for the duration of the study.

          -  Confirmation that the participant is not pregnant must be established by a negative
             serum or urinary hCG test within 7 days prior to start of study treatment. A pregnancy
             test is not required if the participant is post-menopausal or surgically sterile.

        Exclusion Criteria:

          -  Participant has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or
             Secondary Progressive MS without superimposed relapses.

          -  Participant had any prior interferon beta therapy (either beta-1b or beta-1a)

          -  Participant has an ongoing MS relapse.

          -  Participant received any other approved disease modifying therapy for MS (e.g.
             glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior
             to Study Day 1(SD1).

          -  Participant had prior use of cladribine or has previously received total lymphoid
             irradiation.

          -  Participant received oral or systemic corticosteroids or adrenocorticotropic hormone
             (ACTH) within 30 days of SD1.

          -  Participant received intravenous immunoglobulins or underwent plasmapheresis within
             the 6 months prior to SD1.

          -  Participant received immunomodulatory or immunosuppressive therapy (including but not
             limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide,
             mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months
             prior to SD1.

          -  Participant requires chronic or monthly pulse corticosteroids during the study.

          -  Participant received any investigational drug or experimental procedure within 12
             weeks of SD1.

          -  Participant has inadequate liver function, defined by a total bilirubin, aspartate
             aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5
             times the upper limit of the normal values.

          -  Participant has inadequate bone marrow reserve, defined as a white blood cell count
             less than 0.5 x lower limit of normal.

          -  Participant suffers from current autoimmune disease.

          -  Participant 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
             study protocol.

          -  Participant has a known allergy to IFN or the excipients.