Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis

• Conditions: Relapsing Remitting Multiple Sclerosis; MedDRA version: 14.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2007-001161-14-SE
• Lead Sponsor: Genzyme Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-18
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 525

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
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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified