. 2014 Feb 12;7:19–27. doi: 10.2147/JIR.S38079

Table 1.

Eligibility criteria for the CARE-MS-1 and CARE-MS-2 trials

CARE-MS-1 (alemtuzumab as first-line treatment)¹⁶	CARE-MS-2 (alemtuzumab after failure of disease-modifying therapy)¹⁷
Inclusion criteria • Age 18–50 years, either sex • Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years • Onset of MS symptoms within 5 years • EDSS score 0.0–3.0 • ≥2 MS relapses within 24 months, with ≥1 relapse within 12 months Main exclusion criteria • Prior therapy for MS other than corticosteroids • Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment • Previous treatment with a monoclonal antibody for any reason • Any progressive form of MS	Inclusion criteria • Age 18–55 years, either sex • Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS • Onset of MS symptoms within 10 years • EDSS score 0.0–5.0 • ≥2 MS relapses within 24 months, with ≥1 relapse within 12 months • ≥1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for at least 6 months within 10 years Main exclusion criteria • Previous treatment with alemtuzumab • Previous treatment with any investigational drug • Treatment with natalizumab, methotrexate, azathioprine or cyclosporine in the past 6 months • Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, or any other immunosuppressive or cytotoxic therapy (other than steroid treatment) • Any progressive form of MS

CARE-MS-1 (alemtuzumab as first-line treatment)¹⁶

CARE-MS-2 (alemtuzumab after failure of disease-modifying therapy)¹⁷

Inclusion criteria
• Age 18–50 years, either sex
• Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years
• Onset of MS symptoms within 5 years
• EDSS score 0.0–3.0
• ≥2 MS relapses within 24 months, with ≥1 relapse within 12 months
Main exclusion criteria
• Prior therapy for MS other than corticosteroids
• Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment
• Previous treatment with a monoclonal antibody for any reason
• Any progressive form of MS

Inclusion criteria
• Age 18–55 years, either sex
• Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS
• Onset of MS symptoms within 10 years
• EDSS score 0.0–5.0
• ≥2 MS relapses within 24 months, with ≥1 relapse within 12 months
• ≥1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for at least 6 months within 10 years
Main exclusion criteria
• Previous treatment with alemtuzumab
• Previous treatment with any investigational drug
• Treatment with natalizumab, methotrexate, azathioprine or cyclosporine in the past 6 months
• Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, or any other immunosuppressive or cytotoxic therapy (other than steroid treatment)
• Any progressive form of MS

Note: Data from Cohen et al¹⁶ and Coles et al.¹⁷

Abbreviations: EDSS, expanded disability status scale; MRI, magnetic resonance imaging; MS, multiple sclerosis; CARE-MS, Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.