An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy (COMPARE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01141751
First received: June 9, 2010
Last updated: July 11, 2014
Last verified: June 2013
  Purpose

Significant data from placebo-controlled clinical trials have demonstrated the efficacy of Rebif in relapsing remitting multiple sclerosis (RRMS) with reduction in relapse rate, delay in disability progression, and reduction in magnetic resonance imaging (MRI) activity and accumulation of lesion burden. Multiple sclerosis (MS), a chronic neurological diseases, can have diverse effects on the lives of subjects and their families. In controlled clinical trials, clinical measurement in MS has focused on impairments of neurological assessment using Expanded Disability Status Score (EDSS). The assessment of the impact of MS on the non-physical aspect of dysfunction is not often measured, or reported. Furthermore, traditional clinical measures have not been able to assess the effects of neurological illness on quality of life (QoL), which is becoming an increasingly important topic to neurologists treating subjects with varied neurological conditions.

This observational, one arm, multicentric study is aimed to assess the usefulness of the Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) instrument in comparison with the Multiple Sclerosis Quality of Life-54 instrument (MSQOL-54 questionnaire) in RMS subjects on Rebif therapy and to assess the effectiveness of Rebif therapy using health related quality of life (HRQoL) measures.


Condition
Multiple Sclerosis, Relapsing-Remitting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Observational, Open-label, Multi-center Comparison Study of the Newly Developed and Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument With the Health-related QoL (MSQOL-54) Questionnaire in Subjects With Relapsing Forms of Multiple Sclerosis (RMS*) on Rebif® Therapy

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Usefulness of MusiQoL in clinical practice in comparison with the established disease specific QoL instrument MSQOL-54 [ Time Frame: Baseline to 24 months (or Early Termination) ] [ Designated as safety issue: No ]
    The usefulness of the MusiQoL versus the MSQOL-54 questionnaire will be evaluated based on the numbers of missing items; the difficulty of completing each instrument; responses to a subject evaluation questionnaire (the proportion of subjects who prefer MusiQoL versus MSQOL-54 according to their assessment of the best user-friendly QoL questionnaire, time spent to complete each questionnaire and references of the subjects according to the evaluation questionnaire); subject's QoL instrument rating assessed with a VAS (visual analogue scale, ranged from 0 to 10)


Secondary Outcome Measures:
  • Evaluation of QoL instrument scores between baseline and month 24 and the relationship to measures of disease activity (relapses) and disease severity (EDSS) [ Time Frame: Baseline to 24 months (or Early Termination) ] [ Designated as safety issue: No ]
  • Relationship between Folstein mini-mental status examination (MMSE) and Frontal assessment battery (FAB) scores and QoL instrument scores [ Time Frame: Baseline to 24 months (or Early Termination) ] [ Designated as safety issue: No ]
  • Relationship between depression score and QoL instrument scores [ Time Frame: Baseline to 24 months (or Early Termination) ] [ Designated as safety issue: No ]
  • Number of relapses [ Time Frame: Baseline to 24 months (or Early Termination) ] [ Designated as safety issue: No ]
  • Expanded Disability Status Score (EDSS) scores [ Time Frame: Baseline to 24 months (or Early Termination) ] [ Designated as safety issue: No ]
  • Number of progressions on the EDSS score [ Time Frame: Baseline to 24 months (or Early Termination) ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: September 2005
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Multiple sclerosis is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. The neuropathology of the disease is marked by accumulation of leukocytes in the CNS, oligodendrocyte loss, demyelination, axonal atrophy, and neuronal loss. Clinically it is characterized by multi-focal recurrent attacks of neurological symptoms and signs with variable recovery and eventually, the majority of subjects develop a progressive clinical course of MS. The exact cause of MS is unknown, although an autoimmune process has been implicated. Genetic susceptibility plays a role in disease initiation but unidentified environmental factors may also be involved. Three clinical forms of MS are recognized: primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (SPMS) and RRMS. Primary progressive subjects are characterized by slow and steady accumulation of neurological deficits from onset without superimposed attacks. Subjects with RRMS have exacerbations or relapses with subsequent variable recovery (remission). Secondary progressive multiple sclerosis is characterized by the steady accumulation of significant and persistent neurological deficit with or without superimposed relapses.

The concept of quality of life (QoL) is defined by the World Health Organization (WHO) as an individual's perception of his or her life within the cultural context and value system in which he or she lives, in respect to objectives, expectations, norms and worries. It is a very complex and broad concept, influenced at various levels by the subject's physical health state, psychological health state, level of independence, social relations and relationship with the overall surrounding environment. A critical element of HRQoL is that it reflects the subject's assessment of the impact of his/her illness, not the physician's perspective. Professional interest in the concept of QoL has increased over the course of the past years, particularly within the framework of health care programs for chronic diseases. Health related quality of life measures can be subdivided into generic and disease-specific measures. Generic measures are designed to assess subjects with diverse medical conditions and they may not capture all relevant aspects of a specific illness. However, disease-specific measures developed from generic HRQoL tools may not truly reflect perspectives from the subjects with specific diseases. The MusiQoL questionnaire is a subject focused questionnaire being developed by an independent scientific steering committee in conjunction with MS subjects, neurologists, and health economists since 2000.

OBJECTIVES

  • To assess the usefulness of MusiQoL in clinical practice in comparison with the established disease specific QoL instrument MSQOL-54
  • To evaluate the effectiveness of Rebif therapy with respect to HRQoL in a longitudinal study in subjects with RMS

This is an observational, one arm, multicentric study. Quality of life data from the MusiQoL instrument and MSQOL-54 questionnaire, as well as physical health outcomes such EDSS, will be collected bi-annually in subjects with RMS.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with RMS who are eligible for Rebif therapy in Canada

Criteria

Inclusion Criteria:

  • Subjects eligible for Rebif therapy according to indications and clinical use in the Rebif Product Monograph (and subject who agreed to start on Rebif therapy)
  • Subjects who have read, understood, signed and dated the informed consent form

Exclusion Criteria:

  • Subjects who are unable to fill in the questionnaires by him/herself
  • Subjects who have used disease modifying drugs within the last month (or 30 days) prior to study Day 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141751

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible EMD Serono, a division of EMD Inc., Canada
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01141751     History of Changes
Other Study ID Numbers: 00066
Study First Received: June 9, 2010
Last Updated: July 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by Merck KGaA:
Multiple sclerosis
Expanded Disability Status Scale
Multiple Sclerosis, Relapsing-Remitting; Rebif
Beta-1, interferon

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 August 28, 2014