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

NCT01141751 | Completed

• 1 other identifier: 00066
• Study Type: observational
• Target: 334
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple sclerosis; Expanded Disability Status Scale; Multiple Sclerosis, Relapsing-Remitting; Rebif; Beta-1, interferon

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  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

  Baseline to 24 months (or Early Termination)

• Relationship between depression score and QoL instrument scores

  Baseline to 24 months (or Early Termination)

• Number of relapses

  Baseline to 24 months (or Early Termination)

• Expanded Disability Status Score (EDSS) scores

  Baseline to 24 months (or Early Termination)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with RMS who are eligible for Rebif therapy in Canada

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Related Publications (1)

• 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.

  PMID: 26236506 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Responsible

  EMD Serono, a division of EMD Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: September 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 14, 2014

Record last verified: 2013-06