Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects

Study Overview
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Brief Summary
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This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.

Official Title
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A Randomized, Multicenter, Parallel Group, Open-label Study Comparing the Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing Remitting MS Patients

Conditions
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Multiple Sclerosis, Relapsing-remitting

Intervention / Treatment
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* Device: Rebif® via Rebiject™Mini
* Device: Rebif® via manual injections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to 18 years of age Has relapsing-remitting MS Are willing and able to comply with the protocol for the duration of the study Exclusion Criteria: Has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal) Has elevated liver function tests (aspartate aminotransferase [AST], Alanine transaminase [ALT], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal) Has an allergy to human serum albumin or mannitol Had treatment with an investigational product or procedure within 3 months Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study Has concomitant use of Avonex®, Betaseron®, Copaxone®, or Novantrone®

Ages Eligible for Study
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Minimum Age: 18 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® with Rebiject™Mini<br> | Device: Rebif® via Rebiject™Mini<br>* Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.<br>|
| Active Comparator: Rebif® without Rebiject™Mini<br> | Device: Rebif® via manual injections<br>* Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment |  | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with any injection site reactions based on physician assessment |  | Month 3 | 
| Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports |  | Baseline up to Month 3 | 
| Percentage of injection site reactions reported per subject based on subject reports |  | Baseline up to Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS