Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL)

Study Overview
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Brief Summary
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This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.

Official Title
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A Prospective, Observational, International, Multi-center Study to Measure the Relationship Between Relapse and Adherence in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With Rebismart®2.0 + MSdialog™, Assessing Quality of Life (ADHERQOL)

Conditions
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Multiple Sclerosis, Relapsing-remitting

Intervention / Treatment
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* Device: RebiSmart®2.0
* Device: MSdialog™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with RRMS according to McDonald criteria 2010 Relapse free within 30 days before Baseline data collection Treatment with Rebif for 6 months or more prior to informed consent Already using RebiSmart®2.0 + MSdialog™ for patient reported outcome (PRO) assessments (at least once prior to informed consent) Females of childbearing potential must be willing to use appropriate contraception for the duration of the study EDSS score less than (<) 6 Written informed consent obtained prior to any protocol-required data collection Exclusion Criteria: Participation in other studies within 30 days before Baseline Female who is pregnant or breast feeding Significant psychiatric symptoms that, in the opinion of the Investigator, would impact subject ability to comply with treatment (as per standard clinical practice) Any contraindication for Interferon (IFN) beta-1a therapy as per Summary of Product Characteristics (SPC) Administration of any Multiple Sclerosis (MS) therapy, other than Rebif, within 6 months prior to informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsing-remitting Multiple Sclerosis<br> | Device: RebiSmart®2.0<br>* Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.<br>Device: MSdialog™<br>* Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Relapse-free Subjects | Relapse is defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Relapse Rate | Annualized relapse rate is calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25. | Months 12 and 24 | 
| Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™ | Normalized scores are calculated in the range of 0 - 100; where 0 = the worst QoL status and 100 = the best QoL status (as self-assessed by the subject). | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSdialog™, Multiple sclerosis, relapsing-remitting, Rebif, Interferon beta-1a, RebiSmart®2.0