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

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT00548405

Run by

Genzyme, a Sanofi Company

People needed

840

Starts

2007-10-01

Expected to finish

2011-09-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Received prior therapy with alemtuzumab
• Current participation in another clinical study or previous participation in CAMMS323 (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, CARE-MS I)
• Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Participants who received one of these medications more than 6 months before the date the ICF was signed were eligible for study entry if approval was granted by Genzyme
• Any progressive form of MS
• History of malignancy (except basal skin cell carcinoma)
• CD4 +, CD8 +, CD19 + (that is, absolute CD3 + CD4 + , CD3 + CD8 + , or CD19 + /mm 3 ) count, absolute neutrophil count less than (<) lower limit of normal (LLN) at screening; if abnormal cell count(s) returned to within normal limits (WNL), eligibility could be reassessed
• 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 and Medical Center — Phoenix, Arizona, United States
• Hope Research Institute — Phoenix, Arizona, United States
• Mayo Clinic Arizona, Department of Neurology — Scottsdale, Arizona, United States
• Northwest NeuroSpecialists, PLLC — Tucson, Arizona, United States
• East Bay Physicians Medical Group/Sutter East Bay Medical Foundation — Berkeley, California, United States
• Neurology Center of North Orange County — La Habra, California, United States
• Department of Neurology, Keck School of Medicine, University of Southern California — Los Angeles, California, United States
• Neuro-Therapeutics Inc. — Pasadena, California, United States
• Neuro-Therapeutics, Inc — Pasadena, California, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• University of Colorado Hospital, Anschutz Outpatient Pavilioin — Aurora, Colorado, United States
• Neurological Consultants — Denver, Colorado, United States
• Advanced Neurosciences Research — Fort Collins, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• University of Florida Neuroscience Institute — Jacksonville, Florida, United States
• Neurology Associates, P.A. — Maitland, Florida, United States
• Neurological Associates — Pompano Beach, Florida, United States
• Negroski, Stein, Sutherland and Hanes Neurology — Sarasota, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• University of South Florida, Department of Neurology — Tampa, Florida, United States
• Emory University, Department of Neurology — Atlanta, Georgia, United States
• Shepherd Center, Inc. — Atlanta, Georgia, United States
• North Central Neurology Associates, P.C. — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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