EUCTR2007-001161-14-SEActive, not recruitingNot Applicable
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 Scleroris. - CARE MS-I
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Genzyme Corporation
- Enrollment
- 525
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Diagnosis of MS and cranial MRI scan demonstrating white matter
- •lesions attributable to MS within 5 years
- •Onset of MS symptoms within 5 years
- •EDSS score 0.0 to 3.0
- •=2 MS attacks within 24 months, with =1 attack within 12 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 525
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Received prior therapy for MS other than corticosteroids
- •Exposure to immunosuppressive or immunomodulatory agents other
- •than systemic corticosteroid treatment
- •Received treatment with a monoclonal antibody for any reason
- •Previous treatment with any investigational drug (i.e. medication that
- •is not approved at any dose for any indication)
- •Has 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
- •Previous hypersensitivity reaction to any immunoglobulin product
- •Known allergy or intolerance to interferon beta, human albumin, or
- •Intolerance of pulsed corticosteroids, especially a history of steroid
- •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)
Investigators
Similar Trials
Active, not recruiting
Not Applicable
?Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisRelapsing Remitting Multiple SclerosisMedDRA version: 14.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2007-001161-14-PLGenzyme Corporation525
Active, not recruiting
Not Applicable
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 Scleroris. - CARE MS-IRelapsing Remitting Multiple SclerosisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2007-001161-14-GBGenzyme Corporation525
Active, not recruiting
Phase 3
Comparison of Alemtuzumab and Rebif (registered trademark) Efficacy in Multiple Sclerosis, Study OneACTRN12608000435381Genzyme Corporation581
Active, not recruiting
Not Applicable
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisRelapsing Remitting Multiple SclerosisMedDRA version: 14.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2007-001161-14-DEGenzyme Corporation525
Active, not recruiting
Phase 1
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 Scleroris. - CARE MS-IRelapsing Remitting Multiple SclerosisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2007-001161-14-FRGenzyme Corporation525