Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT00530348

Run by

Genzyme, a Sanofi Company

People needed

581

Starts

2007-08-01

Expected to finish

2011-04-01

Last updated by the study team

2014-11-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute, St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Northwest NeuroSpecialists, PLLC — Tucson, Arizona, United States
• Advanced Neurosciences Research — Fort Collins, Colorado, United States
• Neurological Associates — Pompano Beach, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Idaho Falls Multiple Sclerosis Center, PLLC — Idaho Falls, Idaho, United States
• Consultants in Neurology, Ltd. — Northbrook, Illinois, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• MidAmerican Neuroscience Institute — Lenexa, Kansas, United States
• Associates in Neurology, PSC — Lexington, Kentucky, United States
• University of Louisville Research Foundation — Louisville, Kentucky, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• University of Nevada School of Medicine — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University of New Mexico, Health Sciences Center, MS Specialty Clinic — Albuquerque, New Mexico, United States
• Empire Neurology — Latham, New York, United States
• Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C. — Patchogue, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI) — Charlotte, North Carolina, United States
• North Central Neurology Associates, P.C. — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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