A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.

Official Title
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An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Rebif®
* Drug: Avonex®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 55 years Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria Two or more relapses within the preceding 24 months Clinical stability or improving neurological state during the 4 weeks before Study Day 1 Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI Willingness and ability to comply with the protocol for the duration of the study Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized) Exclusion Criteria: Secondary progressive MS, primary progressive MS or progressive relapsing MS Prior use of interferon Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI Psychiatric disorder that is unstable or will preclude safe participation in the study Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1 Elevated liver function tests (Alanine transaminase [ALT], Aspartate transaminase [AST], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1 Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1 Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone Previous use of cladribine or total lymphoid irradiation Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA) Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1 Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebif®<br> | Drug: Rebif®<br>* Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.<br>|
| Active Comparator: Avonex®<br> | Drug: Avonex®<br>* Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of exacerbation-free subjects |  | Week 24 | 
| Percentage of exacerbation-free subjects |  | Week 48 | 
| Percentage of exacerbation-free subjects |  | Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of combined unique (CU) active lesions per subject per scan |  | Week 24 | 
| Total exacerbation count per subject |  | Week 24, 48 and 72 | 
| Mean Number of Time constant 2 (T2) active lesions per subject per scan |  | Week 24, 48 and 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing-remitting Multiple Sclerosis, Rebif®, Avonex®, interferon-beta-1a