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
Overview
- Phase
- Not Applicable
- Intervention
- Rebif
- Conditions
- Relapsing Multiple Sclerosis
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 545
- Locations
- 1
- Primary Endpoint
- Treatment Satisfaction
- Status
- Completed
- Last Updated
- 10 years ago
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).
Investigators
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.
Arms & Interventions
Rebif cohort
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.
Intervention: Rebif
Outcomes
Primary Outcomes
Treatment Satisfaction
Time Frame: 96 weeks
The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.
Secondary Outcomes
- Device satisfaction(96 weeks)
- Evaluation of support services(96 weeks)
- Work Productivity(96 weeks)
- Health Related Quality of Life(96 weeks)
- Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire(96 weeks)