Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two (CARE-MS II)
This study has been completed.
Sponsor:
Genzyme
Collaborator:
Bayer
Information provided by (Responsible Party):
Genzyme
ClinicalTrials.gov Identifier:
NCT00548405
First received: October 22, 2007
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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 magnetic resonance imaging (MRI). 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 3 |
| 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: | Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing 2 Annual Cycles of IV [Low]- and High-Dose Alemtuzumab to 3x Weekly SC Interferon Beta-1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis Patients Who Have Relapsed on Therapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Genzyme:
Primary Outcome Measures:
- Time to Sustained Accumulation of Disability (SAD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients who are relapse free at Year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Change from baseline in EDSS (Expanded Disability Status Scale) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 840 |
| Study Start Date: | October 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: alemtuzumab 12 mg |
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
|
| Experimental: alemtuzumab 24mg |
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.
|
| Active Comparator: interferon beta-1a (Rebif ®) |
Biological: interferon beta-1a (Rebif®)
44 mcg administered 3-times weekly by SC injections for 2 years
|
Detailed Description:
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 or 24 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, patients who receive alemtuzumab may be followed in the CAMMS03409 Extension Study (NCT00930553) for safety and efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be eligible to receive alemtuzumab in the Extension Study.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS
- Onset of MS symptoms within 10 years
- EDSS score 0.0 to 5.0
- ≥2 MS attacks within 24 months, with ≥1 attack within 12 months
- ≥1 MS attack (relapse)during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for at least 6 months within 10 years
Exclusion Criteria:
- Previous treatment with alemtuzumab
- Previous treatment with any investigational drug (i.e. a medication that is not approved at any dose or for any indication)
- Treatment with natalizumab, methotrexate, azothioprine or cyclosporine in the past 6 months
- Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, or any other immunosuppressive, or cytotoxic therapy (other than steroid treatment)
- Any progressive form of MS
- Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
- Major systemic disease that cannot be treated or adequately controlled by therapy
- Active infection or high risk for infection
- Autoimmune disorder (other than MS)
- Impaired hepatic or renal function
- History of malignancy, except basal skin cell carcinoma
- Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- Known bleeding disorder
- Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating
- Current participation in another clinical study or previous participation in CAMMS323 (NCT00530348)
- Previous hypersensitivity reaction to any immunoglobulin product
- Known allergy or intolerance to interferon beta, human albumin, or mannitol
- Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
- Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver
- Inability to undergo MRI with gadolinium administration
- Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548405
Show 194 Study Locations
Show 194 Study LocationsSponsors and Collaborators
Genzyme
Bayer
Investigators
| Study Director: | Medical Monitor | Genzyme Coorporation |
More Information
Publications:
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.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00548405 History of Changes |
| Other Study ID Numbers: | CAMMS32400507, 2007-001162-32, CAMMS324,, ISRCTN70702834, ACTRN12608000426381, NTR1469, CARE-MS II |
| Study First Received: | October 22, 2007 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Austria: Federal Ministry for Health Family and Youth Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada Croatia: Agency for Medicinal Product and Medical Devices Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut Israel: Ministry of Health Italy: The Italian Medicines Agency Mexico: Federal Commission for Sanitary Risks Protection Netherlands: Medical Ethics Review Committee (METC) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Genzyme:
|
Multiple Sclerosis |
Additional relevant MeSH terms:
|
Campath 1G Alemtuzumab 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 Antibodies, Neoplasm Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013