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 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
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.
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.
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