Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis

Inclusion criteria

Each patient was to have met all of the following inclusion criteria to be enrolled in the study:

• 18 years of age or older
• Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
• An Expanded Disability Status Score (EDCC) of 0 to 5.5, inclusive
• Be willing and able to comply with the protocol for the duration of the study period
• Be willing to use adequate "double-barrier" contraceptive methods for the duration of the study period
• If female, must be neither pregnant or breast-feeding
• Written informed consent
• To be enrolled in the treatment phase of the study each patient must have a total of at least 2 new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions seen over the series of 3 pretreatment magnetic resonance imaging (MRI)s.

Exclusion criteria

Patients meeting any of the following exclusion criteria were not to be enrolled in the study:

• Diagnosis of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS)
• Received any investigational drug or experimental procedure within 3 months prior to study day 0
• If the patient has received disease-modifying treatments they must be discontinued prior to study day 0 as follows:

• Cyclophosphamide or mitoxantrone- 6 months prior
• Interferons, glatiramer acetate and azathioprine- 12 weeks prior
• Methotrexate, IV immunoglobulin, cyclosporin, plasma exchange or corticosteroids- 8 weeks prior
• Never have been exposed to Tysabri® (natalizumab)or any other VLA-4 (α4β1)antagonist
• Have an active infection or be considered to be at high risk for developing an infection
• Have a history of hepatitis B, C or human immunodeficiency virus (HIV)
• Have a chest X-ray within 6 months of study day 0 with clinically significant findings or abnormalities
• Have inadequate renal or hepatic function
• Have a known history of cancer, except for distant history (>10 years) of carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
• Received any live, attenuated vaccinations within 30 days prior to study day 0
• Have a history of illicit drug or alcohol abuse within 5 years of study day 0
• Have a history of hypersensitivity to prior monoclonal antibody (mAb) treatment
• Have a history of allergy or sensitivity to Gd
• Have a history that would preclude serial MRI scans