A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects

Study Overview
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Brief Summary
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The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS.

Official Title
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A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects: the ScanSmart Study

Conditions
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Relapsing Remitting Multiple Sclerosis (RRMS)

Intervention / Treatment
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* Device: RebiSmart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18 and 65 years of age Have relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald Criteria (2005) Having an expanded disability status scale (EDSS) of less than 6 at the screening visit or within 2 months prior to the screening visit Stable treatment (defined as treatment after titration period) with RebiSmart administered Rebif new formulation (RNF) 22/44 mcg subcutaneously thrice a week for a minimum of 4 weeks prior to inclusion Previously treated with disease modifying drugs (DMDs) for a minimum of 6 months prior to the screening visit Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either: Post-menopausal or surgically sterile; or Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly , and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomized partner Have a scheduled visit 12 weeks after the inclusion visit Willing and able to comply with the protocol for the duration of the study Have given written informed consent Exclusion Criteria: Have had a relapse within 30 days prior to the first visit Have any contra-indications to treatment with Interferon-beta 1a according to Summary of Product Characteristics Have any other significant disease that in the Investigator's opinion would exclude the subject from the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: RebiSmart|Treatment with Rebif New Formulation using RebiSmart.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence assessment | Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing Remitting Multiple Sclerosis, RebiSmart, Rebif, Adherence