CARE-MS
I Exclusion Criteria
Key Exclusion Criteria
Prior Treatments
- Current participation in another clinical study
- Received prior therapy for MS other than corticosteroids
- Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid
treatment
- Received treatment with a monoclonal antibody for any reason
- Previous treatment with any investigational drug (i.e. medication that is not approved
at any dose for any indication)
Medical Conditions (past or present)
- Has 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’sability
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)