A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Rebif® New Formulation (IFN-beta-1a, RNF); Placebo; Rebif® New Formulation (IFN-beta-1a, RNF)
Intervention description: RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks.; Matching placebo will be administered subcutaneously three times a week for 16 weeks.; RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 to Week 40.
Intervention MeSH terms: Interferon beta-1a; Interferon-beta
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Subjects with relapsing remitting multiple sclerosis

Summary:

      General Note: throughout this record, "Rebif® New Formulation" is used for historical and
      consistency purposes.

      Objectives:

      Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a
      [IFN-beta-1a], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple
      Sclerosis and active disease by means of Magnetic Resonance Imaging (MRI) at the end of 16
      weeks of treatment Secondary: To evaluate the efficacy of RNF by comparing the mean number of
      combined unique (CU) lesions per scan per subject between the initial 16 weeks of placebo
      treatment and 24 weeks of RNF treatment in the same subjects, originally randomized to
      placebo.

      Primary Endpoints: The primary endpoint is the difference between the number of CU active MRI
      lesions at Week 16 in the RNF group (Group 1) versus the placebo group (Group 2).

      Secondary Endpoints: The secondary endpoint is the difference in the mean number of CU active
      MRI lesions per scan per subject over the following treatment periods: Study Day 1 - Week 16
      versus Weeks 17 - 40 for the subjects randomized to Group 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 60 years of age

          -  Female subjects must be neither pregnant nor breast-feeding and must lack
             child-bearing potential, as defined by either: post-menopausal or surgically sterile
             or use an effective method of contraception for the duration of the study

          -  Have Relapsing Remitting Multiple Sclerosis (RRMS) according to the revised McDonald
             criteria 2005

          -  Have brain and/or spinal MRI with findings typical of Multiple Sclerosis (MS)

          -  Have disease duration for more than 12 months

          -  Have disease activity characterized by at least one clinical event and one or more
             Gadolinium-enhancing MRI lesions within the 6 months prior to randomization

          -  Have score of <=5.5 on the Expanded Disability Status Scale (EDSS)

          -  Be willing and able to comply with the protocol for the duration of the study

          -  Have given written informed consent prior to any study-related procedure not part of
             the normal medical practice

        Exclusion Criteria:

          -  Have any disease other than MS that could better explain his/her signs and symptoms

          -  Have complete transverse myelitis or bilateral optic neuritis

          -  Have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or
             immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic
             hormone [ACTH]), or total lymphoid irradiation

          -  Have received within 3 months prior to baseline any approved disease-modifying therapy
             for MS, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis,
             any investigational drug, or experimental procedure

          -  Have received within 30 days prior to baseline oral or systemic corticosteroids or
             ACTH

          -  Other protocol defined exclusion criteria could apply