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OpenTrials
Completed

NCT Number: NCT01601119

Impact of Disease Modifying Therapies (DMTs) and Associated Support Services 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).

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Key information

Conditions

Relapsing Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Please contact the

Merck KGaA Communication Center For Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rebif

Drug

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

Other: Disease modifying therapies (DMT)

Other

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

Primary outcomes

  1. 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

  1. Work Productivity

    Time frame: 96 weeks

    Work Productivity and Activity Impairment (WPAI) Questionnaire

  2. Health Related Quality of Life

    Time frame: 96 weeks

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

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

    Time frame: 96 weeks

  4. 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.

  5. Evaluation of support services

    Time frame: 96 weeks

    Patient evaluation of Manufacturer, Homecare and NHS support services

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Limited, UK

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 17, 2012
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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