Rebif New Formulation (RNF) Quality of Life (QOL) Study
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Rebif New Formulation Non Titrated; Rebif New Formulation Titrated
Intervention description: human interferon beta 1a - Rebif New Formulation; Human interferon beta 1a Rebif New Formulation
Intervention MeSH terms: Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and
      injection site redness Rebif treated subjects with relapsing forms of MS who transition to a
      new formulation of Rebif (RNF).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject with a relapsing form of MS; diagnosis of MS is in accordance with the
             McDonald criteria

          2. Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least
             6 months (24 weeks) prior to study enrollment

          3. Subject currently using Rebiject II and 29 gauge needle

          4. Subject is between 18 and 60 years old inclusive

          5. Subject is able to read and understand English

          6. Subject is willing to follow study procedures

          7. Subject has given written informed consent and signed HIPAA

          8. Female subjects must not be either pregnant or breast-feeding and must lack
             childbearing potential, as defined by either: i) Being post-menopausal or surgically
             sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with
             spermicide, or condom with spermicide, for the duration of the study. (Confirmation
             required within 30 days prior to start of the study)

        Exclusion Criteria:

          1. Use of any other injectable medications on a regular basis during the week prior to
             the screening period or during the screening or treatment periods. Receiving a single
             injection for treatment or prophylaxis of a condition unrelated to the subject's
             multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or
             pneumococcus vaccination) is acceptable

          2. Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within
             3 months prior to study enrollment or at any time during study protocol.

          3. Subjects who have previously been on Rebif New Formulation (RNF).

          4. Subject with progressive forms of Multiple Sclerosis (MS).

          5. Subject with history of any chronic pain syndrome.

          6. Subject has any other disease apart from MS that could better explain the subjects
             signs and symptoms.

          7. Subject has complete transverse myelitis or bilateral optic neuritis.

          8. Subjects that use any investigational drug or experimental procedure within 12 weeks
             of visit 1.

          9. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1
             (prior to enrollment).

         10. Subject 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.

         11. Subject has inadequate bone marrow reserve, defined as a white blood cell count less
             than 0.5 x lower limit of normal.

         12. Subject suffers from other current autoimmune disease.

         13. 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
             study protocol

         14. Subject is pregnant or attempting to conceive

         15. Visual or physical impairment that precludes completion of diaries and questionnaires.