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Sponsors and Collaborators: |
Genzyme Bayer Schering Pharmaceutical |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00548405 |
The purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly blood tests and comprehensive testing every 3 months.
Condition | Intervention | Phase |
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Multiple Sclerosis, Relapsing-Remitting |
Biological: alemtuzumab Biological: interferon beta-1a (Rebif®) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing 2 Annual Cycles of IV 12 mg and 24 mg Alemtuzumab to 3x Weekly SC Interferon Beta-1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis Patients Who Have Relapsed on Therapy |
Estimated Enrollment: | 1200 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: alemtuzumab
12 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12
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2: Experimental |
Biological: alemtuzumab
24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12
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3: Active Comparator |
Biological: interferon beta-1a (Rebif®)
44 mcg administered 3-times weekly by SC injections for 2 years
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Every patient will receive active treatment; there is no placebo. Patients who qualify will be randomly assigned to treatment with either 12mg alemtuzumab, 24 mg alemtuzumab, or Rebif® at a 2:2:1 ratio (ie, there is a 4-in-5 chance patients will be assigned to receive alemtuzumab treatment and a 1-in-5 chance patients will be assigned to receive Rebif® treatment). Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif® will be self-injected 3 times per week for 2 years. All patients will be required to return to their study site every 3 months for neurologic assessment. In addition, a safety-related blood test will be performed at least monthly. Participation in this study will end 2 years after the start of treatment for each patient. Additionally, all patients who receive alemtuzumab will be followed in an extension study for safety for at least 3 years after their last dose alemtuzumab. Patients who receive Rebif® and complete 2 years on study may be eligible to receive alemtuzumab in an extension study.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Primary: CARE-MS Call Center, 888-417-MS-CARE | (Toll-Free US only) | |
Contact: Secondary: Genzyme Medical Information, 800-745-4447 (option 2) | or: 617-768-9000 | medinfo@genzyme.com |
Study Director: | Medical Monitor | Genzyme Coorporation |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CAMMS32400507, CAMMS324 |
Study First Received: | October 22, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00548405 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Mexico: Federal Commission for Sanitary Risks Protection; Brazil: National Health Surveillance Agency; Italy: The Italian Medicines Agency; Netherlands: Medical Ethics Review Committee (METC); Spain: Spanish Agency of Medicines; Belgium: Federal Agency for Medicinal Products and Health Products; Switzerland: Swissmedic; Austria: Federal Ministry for Health Family and Youth; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Ireland: Irish Medicines Board |
Multiple Sclerosis |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Alemtuzumab Interferons Interferon beta 1a |
Interferon-beta Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |