Multiple Sclerosis, Relapsing-RemittingCOMPARENCT01141751
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
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 334 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with RMS who are eligible for Rebif therapy in Canada
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple sclerosis, Expanded Disability Status Scale, Multiple Sclerosis, Relapsing-Remitting; Rebif, Beta-1, interferon
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Usefulness of MusiQoL in clinical practice in comparison with the established disease specific QoL instrument MSQOL-54
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)
Measured: Baseline to 24 months (or Early Termination)
Secondary outcomes (6)
Evaluation of QoL instrument scores between baseline and month 24 and the relationship to measures of disease activity (relapses) and disease severity (EDSS)
Measured: Baseline to 24 months (or Early Termination)
Relationship between Folstein mini-mental status examination (MMSE) and Frontal assessment battery (FAB) scores and QoL instrument scores
Measured: Baseline to 24 months (or Early Termination)
Relationship between depression score and QoL instrument scores
Measured: Baseline to 24 months (or Early Termination)
Number of relapses
Measured: Baseline to 24 months (or Early Termination)
Expanded Disability Status Score (EDSS) scores
Measured: Baseline to 24 months (or Early Termination)
Number of progressions on the EDSS score
Measured: Baseline to 24 months (or Early Termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startSep 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, a division of EMD Inc., Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141751
- Sponsor's protocol ID
- 00066
- Acronym
- COMPARE
- Status last verified
- Jun 2013
- First submitted
- 9 Jun 2010
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vickrey BG, Lee L, Moore F, Moriarty P. EDSS Change Relates to Physical HRQoL While Relapse Occurrence Relates to Overall HRQoL in Patients with Multiple Sclerosis Receiving Subcutaneous Interferon beta -1a. Mult Scler Int. 2015;2015:631989. doi: 10.1155/2015/631989. Epub 2015 Jul 5.
PubMed 26236506
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01141751
- Acronym / sponsor ID
- COMPARE / 00066
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple sclerosis, Expanded Disability Status Scale, Multiple Sclerosis, Relapsing-Remitting; Rebif, Beta-1, interferon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with RMS who are eligible for Rebif therapy in Canada
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
6 secondary outcomes
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)
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)
Relationship between depression score and QoL instrument scores
Time frame: Baseline to 24 months (or Early Termination)
Number of relapses
Time frame: Baseline to 24 months (or Early Termination)
Expanded Disability Status Score (EDSS) scores
Time frame: Baseline to 24 months (or Early Termination)
Number of progressions on the EDSS score
Time frame: Baseline to 24 months (or Early Termination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Derived from this study: PubMed 26236506Vickrey BG, Lee L, Moore F, Moriarty P. EDSS Change Relates to Physical HRQoL While Relapse Occurrence Relates to Overall HRQoL in Patients with Multiple Sclerosis Receiving Subcutaneous Interferon beta -1a. Mult Scler Int. 2015;2015:631989. doi: 10.1155/2015/631989. Epub 2015 Jul 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono, a division of EMD Inc., Canada
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01141751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.