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CompletedNCT01601119Updated May 29, 2015

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

An observational study in Relapsing Multiple Sclerosis, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-29.

Sponsored by Merck KGaA, Darmstadt, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
545
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Relapsing Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • Patient reported outcome
  • Patient reported experience
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 545 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
545 participants (actual)

Groups and cohorts

  • 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

  • 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)

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.

06

What researchers measure

Primary outcomes

  1. Treatment Satisfaction

    The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.

    Time frame: 96 weeks

Secondary outcomes

  1. Work Productivity

    Work Productivity and Activity Impairment (WPAI) Questionnaire

    Time frame: 96 weeks

  2. Health Related Quality of Life

    Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire

    Time frame: 96 weeks

  3. Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire

    Time frame: 96 weeks

  4. Device satisfaction

    Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) is an MS-specific treatment satisfaction questionnaire that evaluates injection system satisfaction and side effects.

    Time frame: 96 weeks

  5. Evaluation of support services

    Patient evaluation of Manufacturer, Homecare and NHS support services

    Time frame: 96 weeks

07

Study locations

1 site
  • Please contact the
    Merck KGaA Communication Center for locations, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01601119
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Limited, UK
Responsible party
Sponsor
First posted
May 17, 2012
Start date
Jan 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
May 29, 2015

Study contacts

Medical Director
study director · Merck Serono Limited, UK

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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