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Sponsors and Collaborators: |
Genzyme Bayer |
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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 laboratory 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: | 700 |
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 Note: The 24 mg alemtuzumab dose is closed to enrollment.
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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. The 24 mg alemtuzumab dose is closed to enrollment so newly enrolled patients will be randomly assigned to treatment with either 12 mg alemtuzumab or Rebif® at a 2:1 ratio (ie, 2 given 12 mg alemtuzumab for every 1 given Rebif®). 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, safety-related laboratory tests 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 and efficacy assessments.
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:
Study Director: | Medical Monitor | Genzyme Coorporation |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CAMMS32400507, CAMMS324,, ISRCTN70702834,, ACTRN12608000426381,, NTR1469 |
Study First Received: | October 22, 2007 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00548405 History of Changes |
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; Israel: Ministry of Health; Serbia: Agency for Drugs and Medicincal Devices of Serbia |
Multiple Sclerosis |
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Interferons Adjuvants, Immunologic Interferon-beta Sclerosis |
Multiple Sclerosis, Relapsing-Remitting Antiviral Agents Multiple Sclerosis Alemtuzumab Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Interferons Adjuvants, Immunologic Interferon-beta |
Sclerosis Antiviral Agents Multiple Sclerosis, Relapsing-Remitting Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Alemtuzumab Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |