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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01601119

Enrollment

545

Registered

2012-05-17

Start date

2012-01-31

Completion date

2014-07-31

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Keywords

Multiple Sclerosis, Patient reported outcome, Patient reported experience

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).

Interventions

DRUGRebif

The subjects will receive Rebif as per the current practices or as directed by the physician.

OTHEROther: Disease modifying therapies (DMT)

The subjects will receive other DMTs as per the current practices or as directed by the physician.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Treatment Satisfaction	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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026