A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
Recruiting in Palo Alto (17 mi)
+48 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Genzyme, a Sanofi Company
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previously treated with MS therapies other than steroids. The study was conducted for an initial period of 3 years and a follow-up to 5 years or more.
Eligibility Criteria
Inclusion Criteria
Signed informed consent form (ICF)
Male or non-pregnant, non-lactating female participants, 18 to 50 years of age (inclusive) as of signing the ICF
Diagnosis of MS per McDonald's update of the Poser criteria, including cranial MRI consistent with those criteria (McDonald, 2001, Ann Neurol)
See 4 more
Treatment Details
Interventions
- Alemtuzumab (Monoclonal Antibodies)
- Interferon beta-1a (Interferon)
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Alemtuzumab 24 mgExperimental Treatment1 Intervention
Group II: Alemtuzumab 12 mgExperimental Treatment1 Intervention
Group III: Interferon Beta-1aActive Control1 Intervention
Alemtuzumab is already approved in United States, European Union, European Union for the following indications:
🇺🇸 Approved in United States as Campath for:
- Chronic lymphocytic leukemia
- Multiple sclerosis
🇪🇺 Approved in European Union as Lemtrada for:
- Multiple sclerosis
🇪🇺 Approved in European Union as Campath for:
- Chronic lymphocytic leukemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nevada Neurological Consultants, Ltd.Las Vegas, NV
Neurology Center of San AntonioSan Antonio, TX
Fort Wayne Neurological CenterFort Wayne, IN
Michigan Medical P.C. NeurologyGrand Rapids, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Genzyme, a Sanofi CompanyLead Sponsor
BayerIndustry Sponsor