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

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ClinicalTrials.gov Identifier: NCT01601119
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA

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).

Condition or disease Intervention/treatment
Relapsing Multiple Sclerosis Drug: Rebif Other: Other: Disease modifying therapies (DMT)

Study Type : Observational
Actual Enrollment : 545 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601119


Locations
United Kingdom
Please contact the
Merck KGaA Communication Center for locations, United Kingdom
Sponsors and Collaborators
Merck KGaA
Merck Serono Limited, UK
Investigators
Study Director: Medical Director Merck Serono Limited, UK

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01601119     History of Changes
Other Study ID Numbers: EMR200136_550
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents