An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

Study Overview
=================
Brief Summary
-----------------
This is an observational, retrospective, UK & Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.

Official Title
-----------------
REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

Conditions
-----------------
Relapsing Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland) Be willing to give consent for their adherence data to be captured in the audit Exclusion Criteria: Patients who do not fulfill entirely the inclusion criteria as well as the following: Discontinued Rebif before 24 months of treatment Unable or unwilling to give consent for their adherence data to be captured in the audit

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Adherence | Percentage RebiSmart measured patient adherence to Rebif® injections | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Adherence | Percentage RebiSmart measured patient adherence to Rebif® injections | 1 month | 
| Patient Adherence | Percentage RebiSmart™ measured patient adherence to Rebif® injections | 3 months | 
| Patient Adherence | Percentage RebiSmart™ measured patient adherence to Rebif® injections | 6 months | 
| Patient Adherence | Percentage RebiSmart™ measured patient adherence to Rebif® injections | 12 months | 
| Difference in patient adherence over time | Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period. | 12 months | 
| Medication Possession Ratio | Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels | 12 months | 
| Medication Possession Ratio | Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels | 24 months | 
| Adherence of patient subgroups | RebiSmart™ measured percentage adherence within and between the following patient sub-groups: patients who are and are not registered to MySupport (Rebif Support Programme) patient age groups patient gender prior use of a DMT | 12 months | 
| Adherence of patient subgroups | RebiSmart™ measured percentage adherence within and between the following patient sub-groups: patients who are and are not registered to MySupport (Rebif Support Programme) patient age groups patient gender prior use of a DMT | 24 months | 
| Patient Adherence in the UK versus Ireland | Reporting of UK and Ireland actual adherence levels separately | 12 months | 
| Patient Adherence in the UK versus Ireland | Reporting of UK and Ireland actual adherence levels separately | 24 months | 
| Device Comfort Settings | Preferred final comfort settings (at last injection) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence, Multiple Sclerosis