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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

This study is currently recruiting participants.
Verified February 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01601119
First received: May 15, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention
Relapsing Multiple Sclerosis
 Drug: Rebif
Other: other disease modifying therapies (DMT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Treatment Satisfaction [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.


Secondary Outcome Measures:
  • Work Productivity [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Work Productivity and Activity Impairment (WPAI) Questionnaire

  • Health Related Quality of Life [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Multiple Sclerosis Impact Scale (MSIS-29) v2.0 Questionnaire

  • Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionaire [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • Device satisfaction [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Patient evaluation of Manufacturer, Homecare and NHS support services


Estimated Enrollment: 346
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1 Drug: Rebif
Cohort 2 Other: other disease modifying therapies (DMT)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601119

Contacts
Contact: Laura Parkes +44-208-818-7200 laura.parkes@merckgroup.com

Locations
United Kingdom
Please conatact the Recruiting
Merck KGaA Communication Center for recruiting locations, United Kingdom
Contact: Merck KGaA Communication Center     +49 6151 72 5200     service@merck.de    
Sponsors and Collaborators
Merck KGaA
Merck Serono Limited, UK
Investigators
Study Director: Medical Director Merck Serono Limited, UK
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01601119     History of Changes
Other Study ID Numbers: EMR200136_550
Study First Received: May 15, 2012
Last Updated: February 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Merck KGaA:
Multiple Sclerosis
Patient reported outcome
Patient reported experience

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013