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Department of Neurology

Oral Cladribine and Rebif® New Formulation

A Phase II Cladribine and Add-on Rebif® New Formulation in MS Subjects with Active Disease

Study Duration
A 72 Week analysis is planned.

Key Inclusion Criteria

  1. Be male or Female, 18-55 years of age
  2. Weigh between 40-120kg
  3. Have definite MS, as confirmed by McDonald criteria, and having relapsing forms of MS
  4. Have experience at least on relapse while receiving Rebif® for at least 48 weeks
  5. Be clinically stable during the 28 days preceding screening
  6. Have and EDSS from 1.0-5.5
  7. Have not received more than on DMD other then Rebif® during MS treatment history
  8. Have no prior exposure to immunosuppressive or cytotoxic agents
  9. If female, must be either:
    1. Post-menopausal or surgically sterilized
    2. Use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide
    3. Be neither pregnant, breast-feeding or attempting to conceive
  10. If male, must be willing to use contraceptive to avoid pregnancy
  11. Be willing and able to comply with study procedures for the duration of the study
  12. Voluntarily provide written Informed Consent

Key Exclusion Criteria

  1. Have Primary Progressive MS or secondary progressive MS without relapsing forms
  2. Have prior or current malignancy
  3. Have a history or chronic or clinically significant hematologic abnormalities
  4. Have platelet, absolute neutrophil or absolute lymphocyte counts below the lower limit of normal range or significant leucopenia within 28 days prior to Study Day 1
  5. Prior use of cladribine, mitoxantrone, campath-1h, cyclophosphamide, azathioprine, methotrexate, natalizumab, lymphoid irradiation, bone marrow transplantation or myelosuppressive/cytotoxic therapy
  6. Use of cytokine or anti-cytokine therapy, IVIG, or plasmapheresis within 3 month prior to Study Day 1
  7. Subject requires chronic or monthly pulse corticosteroids during the study
  8. Use of any investigational drugs or experimental procedure within 6 months prior to Study Day 1
  9. Subject has inadequate liver function, defined by total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALT) >2.5 times the upper limit of the normal values
  10. Subject suffers from major medical or psychiatric illness that in the opinion of the investigator created undue risk to the subject or could affect compliance with the study protocol
  11. Have compromised immune function or ongoing infection
  12. Have a allergy or hypersensitivity to gadolinium, to cladribine or any of its excipients, or Rebif® or any of its excipients.  

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