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

May 28, 2015 updated by: Merck KGaA, Darmstadt, Germany

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Merck KGaA Communication Center for locations, United Kingdom
        • Please contact the

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in the UK newly diagnosed with RMS (and naive to previous DMT) and receiving a DMT that can be self-administered

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Rebif
The subjects will receive Rebif as per the current practices or as directed by the physician.
Other DMT cohort
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)
The subjects will receive other DMTs as per the current practices or as directed by the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work Productivity
Time Frame: 96 weeks
Work Productivity and Activity Impairment (WPAI) Questionnaire
96 weeks
Health Related Quality of Life
Time Frame: 96 weeks
Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire
96 weeks
Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire
Time Frame: 96 weeks
96 weeks
Device satisfaction
Time Frame: 96 weeks
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
Time Frame: 96 weeks
Patient evaluation of Manufacturer, Homecare and NHS support services
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Limited, UK

Investigators

  • Study Director: Medical Director, Merck Serono Limited, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR200136_550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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