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

CompletedPhase 3

Sponsor: Genzyme, a Sanofi Company

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: Alemtuzumab 12 mg, Alemtuzumab 24 mg, Interferon beta-1a

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Exclusion Criteria:

* 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

Locations (191)

Cullman, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Berkeley, California, United States
La Habra, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Pasadena, California, United States
Sacramento, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
Pompano Beach, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Northbrook, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
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