ABOUT THIS STUDY
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.
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
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
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
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.
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