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| Sponsor: | Genzyme |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00050778 |
Purpose
This is a Phase II, randomized, open-label, three-arm study comparing two different doses of alemtuzumab and Rebif® in patients with early, active relapsing-remitting Multiple Sclerosis (MS) who have not been previously treated with MS therapies other than steroids.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Biological: interferon beta-1a (Rebif®) Biological: alemtuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis |
| Enrollment: | 334 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Biological: interferon beta-1a (Rebif®)
44 mcg administered 3-times weekly by SC injections for 36 months.
|
| Experimental: 2 |
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; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments. After initial 36-month treatment period, eligible consenting patients will receive re-treatment on either a fixed schedule (2 annual cycles of 12 mg per day for 3 consecutive days) or an as-needed schedule (up to 2 cycles at least 12 months apart of 12 mg per day for 3 consecutive days only upon MS relapse or new brain abnormalities on MRI) |
| Experimental: 3 |
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; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments. After the initial 36-month treatment period, eligible consenting patients will receive retreatment on either a fixed schedule (2 annual cycles of 12 mg per day for 3 consecutive days) or an as-needed schedule (up to 2 cycles at least 12 months apart of 12 mg per day for 3 consecutive days only upon MS relapse or new brain abnormalities on MRI) |
The aims of treatment for multiple sclerosis (MS) therapy are to prevent the progression of disease and accumulation of long-term disability. The hypothesis underlying this study is that aggressive treatment of inflammation in the brain early in the course of MS will protect the patient from disease progression and accumulating disability.
This protocol compares two different doses of alemtuzumab and Rebif® to evaluate the kind of side effects that patients experience and to evaluate wich drug is better at:
Patients who receive alemtuzumab during the initial 36-month treatment period may be eligible for additional alemtuzumab retreatment on either a fixed or an as-needed schedule to evaluate:
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 42 Study Locations| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00050778 History of Changes |
| Other Study ID Numbers: | CAMMS223 |
| Study First Received: | December 19, 2002 |
| Results First Received: | November 3, 2008 |
| Last Updated: | July 13, 2009 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Croatia: Ministry of Health and Social Care Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health and Social Development of the Russian Federation |
|
Multiple Sclerosis Active Relapsing-Remitting Multiple Sclerosis |
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta Interferons Interferon beta 1a |
Campath 1G Antibodies, Neoplasm Alemtuzumab Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic Immunosuppressive Agents |