The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months. The secondary objectives are: To investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol), sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking at different times points after initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced exhaustion, speed of walking, status of MS disease progression and amount of walking are measured at 6 and 12 months. To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to document any changes in fatigue related medication.
Study Type
OBSERVATIONAL
Enrollment
195
Participants treated with Tysabri
Research Site
Graz, Austria
Research Site
Innsbruck, Austria
Research Site
Salzburg, Austria
Research Site
Vienna, Austria
Research Site
Villach, Austria
Research Site
Aarhus, Denmark
Research Site
Copenhagen, Denmark
Research Site
Odense, Denmark
Research Site
Bergen, Norway
Research Site
Bodø, Norway
...and 17 more locations
To investigate the MS related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months.
A fatigue scale for motor and cognitive functions (FSMC) has been developed and validated by Penner et al. FSMC differentiates between motor and cognitive fatigue and is less susceptible to confounding by depression. Thus, FSMC is more specific in measuring MS-related fatigue.
Time frame: 0 month and 12 months
Changes in fatigue after initiation of Tysabri treatment
Time frame: 3 months, 6 months, 9 months
Change in capacity for work (capacity for work questionnaire (CWQ)) at different points after initiation of Tysabri treatment
Capacity for Work Questionnaire (CWQ) is used to collect data regarding number of working hours and sickness absence.
Time frame: 0, 6 months, 12 months
Change in health-related-quality of life (HRQ0L) (short form-12 questions (SF-12)) at different points after initiation of Tysabri treatment
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall HRQOL. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame: 0, 6 months, 12 months
Change in Sleepiness (Epworth sleepiness scale (ESS)) at different points after initiation of Tysabri treatment
The ESS is a self-administered 8-item questionnaire with that provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. Each question is rated on a 4-point scale (0 - 3), their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives, although not necessarily every day. The total ESS score is the sum of 8 item-scores and can range between 0 and 24, where higher scores indicate higher levels of a person's level of daytime sleepiness.
Time frame: 0, 6 months, 12 months
Change in cognitive impairment (the paced auditory serial addition test (PASAT) and symbol digit modalities test (SDMT)) at different points after initiation of Tysabri treatment
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The PASAT is the third and last component of the MSFC. SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).
Time frame: 0, 6 months, 12 months
Change in depression (Center for epidemiologic studies depression scale (CES-D)) at different points after initiation of Tysabri treatment
CES-D is a self-report measure of depression severity.
Time frame: 0, 6 months, 12 months
Change in Physical activity induced exhaustion (Borg scale CR10 (BS-CR10)) at different points after initiation of Tysabri treatment
The Borg Scale measures perceived exertion. It is used to document the patient's exertion during a test. It ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion.
Time frame: 0, 6 months, 12 months
Change in speed of walking (6MWT) at different points after initiation of Tysabri treatment
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time frame: 0, 6 months, 12 months
Change in status of MS disease progression (expanded disability status scale (EDSS)) at different points after initiation of Tysabri treatment
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Time frame: 0, 6 months, 12 months
Change in amount of walking (step counter) at different points after initiation of Tysabri treatment
Time frame: 0, 6 months, 12 months
To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression
Time frame: 6 months, 12 months
To document any changes in fatigue related medication
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.