A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada?) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • biological : Alemtuzumab 12 mg
  • biological : Interferon beta-1a
  • biological : Alemtuzumab 24 mg

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - 55 Years

Inclusion Criteria

- Signed informed consent form (ICF) - Age 18 to 55 years (inclusive) as of the date the ICF was signed - Diagnosis of MS per update of McDonald criteria - Onset of MS symptoms (as determined by a neurologist; could be retrospectively) within 10 years of the date the ICF was signed - Expanded Disability Status Scale (EDSS) score 0.0 to 5.0 (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 - >=1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for >=6 months within 10 years of the date the ICF was signed - MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist: >=9 time constant 2 (T2) lesions at least 3 millimeter (mm) in any axis; a gadolinium- (Gd-) enhancing lesion at least 3 mm in any axis plus >=1 brain T2 lesions; and a spinal cord lesion consistent with MS plus >=1 brain T2 lesion

External Links

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Contact information

Primary Contact:

Maria Coburn 6507369551

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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