Cladribine Study Inclusion/Exclusion Criteria

Inclusion Criteria

 

1.         Be male or female, 18-55 years of age (inclusive);

2.         Weigh between 40 – 120 kg (88-265 lbs), inclusive;

3.         Have definite MS, as confirmed by the revised McDonald criteria (Polman, et al 2005), and have relapsing forms of MS, such as relapsing-remitting or secondary progressive type of disease with superimposed relapses forms;

4.         Have experienced at least one relapse while receiving RebifÒfor at least 48 weeks prior to screening;

5.         Be clinically stable (other than an MS relapse) during the 28 days preceding Screening;

6.         Have an EDSS from 1.0-5.5, inclusive;

7.         Have not received more than one DMD other than RebifÒ during MS treatment history;

8.         Have no prior exposure to immunosuppressive or cytotoxic agents;

9.         If female, must either:

a)         be post-menopausal or surgically sterilized; or

b)         use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and

c)         be neither pregnant nor breast-feeding, nor attempting to conceive; *

10.       If male, must be willing to use contraception to avoid pregnancies;

11.       Be willing and able to comply with study procedures for the duration of the study;

12        Have not met any of the exclusion criteria outlined in this protocol;

13.       Voluntarily provide written informed consent, including, for USA, subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, and with the understanding that the subject may withdraw consent at any time without prejudice to their future medical care. 

*          Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 28 days prior to Study Day 1 and a negative urine pregnancy test on Study Day 1.  A pregnancy test is not required if the subject is post-menopausal or surgically sterilized.

 

Exclusion Criteria

 

1.   Have primary progressive MS or secondary progressive MS without relapses forms;

2.   Have prior or current malignancy;

3.   Have a history of chronic or clinically significant hematologic abnormalities;

4.   Have platelet, absolute neutrophil or absolute lymphocyte counts below the lower limit of normal range or significant leukopenia (white blood cell count <0.5 times the lower limit of normal of the central laboratory) 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, intravenous immunoglobulin (IVIG) or plasmapheresis within 3 months prior to Study Day 1;

7.   Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1;

8.   Subject requires chronic or monthly pulse corticosteroids during the study;

9.   Use of any investigational drug or experimental procedure within 6 months prior to Study Day 1;

10. Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values;

11. 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;

12. Have compromised immune function (e.g. HIV+) or ongoing infection;

13. Have an allergy or hypersensitivity to gadolinium, to cladribine or any of its excipients, or Rebif® or any of its excipient(s).