CARE-MS
II Exclusion Criteria
Key Exclusion Criteria
Prior Treatments
- Previous treatment with alemtuzumab
- Current participation in another clinical study or previous participation in CAMMS323
- Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past
6 months
- Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or
any other immunosuppressant, or cytotoxic therapy (other than steroid treatment)
- Previous treatment with any other investigational drug (i.e. medication that is
not approved at any dose for any indication)
Medical Conditions (past or present)
- Any progressive form of MS
- History of malignancy, except basal skin cell carcinoma
- Autoimmune disorder (other than MS)
- Active infection or high risk for infection
- Medical, psychiatric, cognitive, or other conditions that compromise the patient’s
ability to understand the patient information, to give informed consent, to comply
with the trial protocol, or to complete the study
- Major systemic disease that cannot be treated or adequately controlled by therapy
- Any disability acquired from trauma or another illness that could interfere with
evaluation of disability due to MS
- Of childbearing potential with a positive serum pregnancy test, pregnant or lactating
- Impaired hepatic or renal function
Inability to Tolerate Study-Associated Drugs or Procedures
- Known bleeding disorder
- Previous hypersensitivity reaction to any immunoglobulin product
- Known allergy or intolerance to interferon beta, human albumin, or mannitol
- Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
- Inability to self-administer subcutaneous (SC) injections or receive SC injections
from caregiver
- Inability to undergo MRI with gadolinium administration
- Unwilling to use a reliable and acceptable contraceptive method throughout the study
period (fertile patients only)