Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The study will enroll patients who have not previously received treatment to suppress Multiple Sclerosis (MS).<br>The main objective of this study is to establish the efficacy of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS) in comparison with Rebif® (interferon beta-1a).;Secondary Objective: Secondary objective of the CAMMS323 trial is to establish the safety of alemtuzumab as a treatment for relapsing-remitting MS, in comparison with Rebif® (interferon beta-1a).;Primary end point(s): •Time to Sustained Accumulation of Disability (SAD)<br>•Relapse Rate;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Proportion of patients who are relapse free at Year 2<br>•Change from baseline in EDSS (Expanded Disability Status Scale)<br>•Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC)<br>•Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2;Timepoint(s) of evaluation of this end point: 24 months

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