Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients

Study Overview
=================
Brief Summary
-----------------
The objective is to establish the impact of current disease modifying therapies (DMTs) and associated support services on Patient Reported Experience Measures and Patient Reported Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the United Kingdom (UK).

Official Title
-----------------
The Impact of Disease Modifying Therapies (DMTs) and Associated Support Services on Patient Reported Experience Measures (PREMs) and Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

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

Intervention / Treatment
-----------------
* Drug: Rebif
* Other: Other: Disease modifying therapies (DMT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing Multiple Sclerosis patients aged 18 years or over. Naive to previous DMT therapy and not yet started treatment with a disease modifying therapy. Exclusion Criteria: Participating in an MS-related clinical trial. Unwilling to provide electronic online consent. Any disability that may impair them from being able to complete the online questionnaire. Do not have regular access to the Internet. Unable to complete the baseline questionnaire before they receive their first DMT injection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rebif cohort<br>Subject will receive Rebif as the treatment medication as per the standard or current practices or as directed by the healthcare professional. Allocation of subjects to a specific cohort was based on the first DMT they will be prescribed regardless of any subsequent treatment switches. | Drug: Rebif<br>* The subjects will receive Rebif as per the current practices or as directed by the physician.<br>|
| Other DMT cohort<br>Subjects will receive DMT other than Rebif as per the standard or current practices or as directed by the healthcare professional. Allocation of subjects to a specific cohort was based on the first DMT they will be prescribed regardless of any subsequent treatment switches. | Other: Other: Disease modifying therapies (DMT)<br>* The subjects will receive other DMTs as per the current practices or as directed by the physician.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Satisfaction | The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts. | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Productivity | Work Productivity and Activity Impairment (WPAI) Questionnaire | 96 weeks | 
| Health Related Quality of Life | Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire | 96 weeks | 
| Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire |  | 96 weeks | 
| Device satisfaction | Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) is an MS-specific treatment satisfaction questionnaire that evaluates injection system satisfaction and side effects. | 96 weeks | 
| Evaluation of support services | Patient evaluation of Manufacturer, Homecare and NHS support services | 96 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Patient reported outcome, Patient reported experience