Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Alemtuzumab; Interferon beta-1a
Intervention description: Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.; Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Alemtuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 581.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis

Summary:

      The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™)
      as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with
      subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had
      not previously received MS disease-modifying therapies. Participants had monthly laboratory
      tests and comprehensive testing every 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Given written/signed informed consent

          -  Age 18 to 50 years old (inclusive) as of the date the informed consent form (ICF) was
             signed

          -  Diagnosis of MS per updated McDonald criteria, and cranial magnetic resonance imaging
             (MRI) scan demonstrating white matter lesions attributable to MS within 5 years of
             screening

          -  Onset of MS symptoms (as determined by a neurologist, either at screening or
             retrospectively) within 5 years of the date the ICF was signed

          -  Expanded Disability Status Scale (EDSS) score 0.0 to 3.0 (inclusive) at screening

          -  Greater than or equal to (>=) 2 MS attacks (first episode or relapse) occurring in the
             24 months prior to the date the ICF was signed, with >=1 attack in the 12 months prior
             to the date the ICF was signed, with objective neurological signs confirmed by a
             physician, nurse practitioner, or other Genzyme-approved health-care provider and the
             objective signs could be identified retrospectively

        Exclusion Criteria:

          -  Received prior therapy for MS other than corticosteroids, for example, alemtuzumab,
             interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and
             mitoxantrone

          -  Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate,
             or any other immunosuppressive agent other than systemic corticosteroid treatment

          -  Any progressive form of MS

          -  History of malignancy (except basal skin cell carcinoma)

          -  CD4 + , CD8 + count, B cell, or absolute neutrophil count less than (<) lower limit of
             normal (LLN) at screening

          -  Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency,
             hemophilia, Von Willebrand's disease, disseminated intravascular coagulation,
             fibrinogen deficiency, or clotting factor deficiency)

          -  Significant autoimmune disease including but not limited to immune cytopenias,
             rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders,
             vasculitis, inflammatory bowel disease, severe psoriasis

          -  Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that
             is, above the LLN)

          -  Active infection or at high risk for infection