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| Sponsor: | Genzyme |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00530348 |
Purpose
The purpose of this study is to establish the efficacy and safety 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 not previously received treatment to suppress MS, except steroids. Patients will have monthly laboratory tests and comprehensive testing every 3 months.
| Condition | Intervention | Phase |
|---|---|---|
|
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: | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis |
| Enrollment: | 581 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| alemtuzumab 12 mg: 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.
|
| interferon beta-1a (Rebif ®) 44mcg: Active Comparator |
Biological: interferon beta-1a (Rebif®)
44 mcg administered 3-times weekly by SC injections for 2 years
|
Every patient will receive active treatment; there is no placebo. Patients who qualify will be randomly assigned to treatment with either alemtuzumab or Rebif® at a 2:1 ratio (ie, 2 given 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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 101 Study Locations| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | CAMMS323, ISRCTN21534255,, ACTRN12608000435381 |
| Study First Received: | September 13, 2007 |
| Last Updated: | December 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00530348 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; Croatia: Ministry of Health and Social Care; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Ukraine: State Pharmacological Center - Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Russia: Ministry of Health and Social Development of the Russian Federation; Mexico: Federal Commission for Sanitary Risks Protection; Brazil: National Health Surveillance Agency |
|
Multiple Sclerosis |
|
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 |