CARE-MS
Study Design
About the Studies
CARE-MS I and II studies are designed to determine the safety and effectiveness
of the investigational drug alemtuzumab as compared to the FDA-approved therapy
Rebif® (interferon beta-1a) in people with RRMS. CARE-MS I will study treatment-naïve
RRMS patients, and CARE-MS II will involve patients who have been previously treated
and relapsed.
For both CARE-MS studies, participants will be randomly assigned to receive treatment
with either alemtuzumab or Rebif for 2 years. Participants treated with alemtuzumab
will receive intravenous infusions daily for the first 5 days of the first year
and daily for the first 3 days of the second year. Study participants receiving
Rebif will be given injections under the skin 3 times per week throughout both years
of the study period. Rebif can be self-administered or administered by a caregiver.
Study participants will undergo periodic health assessments during the two-year
time period of the study. Participants receiving alemtuzumab will be followed for
safety in an extension study for at least three years after their last dose. Participants
may be asked to take part in neurological evaluations to determine if any lasting
treatment benefits exist. At the completion of the two-year study, participants
receiving Rebif may be eligible to receive alemtuzumab in an extension study.
Total recruitment goals are 525 participants for CARE-MS I and 1,200 participants
for CARE-MS II. For CARE-MS I, more than 100 study sites are participating worldwide.
CARE-MS II will include more than 200 sites worldwide.
About Alemtuzumab
Alemtuzumab is a humanized monoclonal antibody that targets the CD52 antigen present
on T and B lymphocytes, NK cells, monocytes, and macrophages, among other cell types.
Alemtuzumab is being studied as a potential treatment of MS. Since it is not approved
to treat MS, alemtuzumab must not be used in individuals with MS outside of a formal
regulated clinical trial setting.