RNF and Betaseron® Tolerability Study
Condition: Relapsing Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: New Formulation of rebif - human interferon beta-1a; Interferon beta -1b
Intervention description: New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.; Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with
      relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site
      pain scores from pre-injection to 30 minutes post therapy administration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject with diagnosis of RRMS according to McDonald criteria or Poser

          2. Subject is between 18 and 60 years old inclusive

          3. Subject is willing to follow study procedures

          4. Subject has given written informed consent

          5. Female subjects 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.

        Exclusion Criteria:

          1. Subject has Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary
             Progressive MS without superimposed relapses.

          2. Subject has had any prior interferon beta therapy (either beta-1b or beta-1a) prior to
             study Day 1.

          3. Subject received any other approved disease modifying therapy for MS (glatiramer
             acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to Study
             Day 1.

          4. Subject received immunomodulatory or immunosuppressive therapy (including but not
             limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide,
             mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath and cladribine) within
             the 12 months prior to Study Day 1.

          5. Subject had prior use of Cladribine or has previously received total lymphoid
             irradiation.

          6. Subject has known allergy to natural or recombinant interferon or any other component
             of formulation excipient(s) of Rebif® or Betaseron®: Mannitol, Poloxamer 188,
             Methionine, Benzyl alcohol or Albumin (human).

          7. 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® or Betaseron® therapy (e.g. receiving a
             influenza or pneumococcus vaccination) is acceptable.

          8. History of any chronic pain syndrome.

          9. Subject has any other disease apart from MS that could better explain the subjects
             signs and symptoms.

         10. Subject has complete transverse myelitis or bilateral optic neuritis.

         11. Subjects who used any investigational drug or experimental procedure within 12 weeks
             prior to visit 1.

         12. 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.

         13. Subject has inadequate bone marrow reserve, defined as a white blood cell count less
             than 0.5 x lower limit of normal.

         14. Subject suffers from current autoimmune disease (other than RRMS).

         15. 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

         16. Subject is pregnant or attempting to conceive

         17. Visual or physical impairment that precludes completion of diaries and questionnaires.

         18. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1.