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Sponsors and Collaborators: |
Genzyme Bayer Schering Pharma AG |
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 |
Multiple Sclerosis, Relapsing-Remitting |
Biological: alemtuzumab Biological: interferon beta-1a (Rebif®) |
Phase III |
MedlinePlus related topics: | Multiple Sclerosis |
ChemIDplus related topics: | Alemtuzumab Interferon alfa-2b Interferons Campath Interferon beta Interferon-beta Interferon beta 1a |
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 |
Arms | Assigned Interventions |
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: Medical Information | 800-745-4447 | medinfo@genzyme.com |
Contact: Medical Information | 617-768-9000 | medinfo@genzyme.com |
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Show 134 Study Locations |
Genzyme |
Bayer Schering Pharma AG |
Study Director: | Medical Monitor | Genzyme Coorporation |
US FDA Approved Full Prescribing Information for alemtuzumab (Campath®) 
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Coles AJ, Cox A, Le Page E, Jones J, Trip SA, Deans J, Seaman S, Miller DH, Hale G, Waldmann H, Compston DA. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006 Jan;253(1):98-108. Epub 2005 Jul 27.
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Fox E, Sullivan H, Gazda S. Open label, single-arm, Phase II study of alemtuzumab in patients with active relapsing-remitting multiple sclerosis who have failed licensed beta-interferon therapies. Poster presentation P06.07 at the 59th Annual Meeting of the American Academy of Neurology (AAN) on 03 May 2007.
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Bass, A., and the CAMMS223 International Study Group. 2007. Consistent Efficacy of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Across Major Demographic Subgroups: Interim Analysis after Two Years of Study CAMMS223. Mult Scler 13 (9): 1220-1221.
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Coles, A., and the CAMMS223 Study Group. Alemtuzumab improved multiple sclerosis functional composite scores and delayed time to first relapse at 2-year interim analysis compared to subcutaneous interferon beta-1a. 2007. Presented at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Prague, Czech Republic, Oct 11-14, 2007.
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Coles, A. J., and the CAMMS223 Study Group. Alemtuzumab Compared with Subcutaneous High-Dose IFNB-1a in Treatment-Naive Relapsing-Remitting Multiple Sclerosis: Primary Efficacy Outcomes of CAMMS223 at 3 Years. 2008. Presented at the 60th Annual Meeting of the American Academy of Neurology, Chicago, IL.
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Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CAMMS32400507, CAMMS324 |
First Received: | October 22, 2007 |
Last Updated: | October 7, 2008 |
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 |
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