Clinical trial NCT00884481: Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS
Official title: A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Fatigue
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with Relapsing Remitting Multiple Sclerosis initiating treatment with Tysabri

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* Tysabri prescribed according to national guidelines but not yet started treatment
* Signed informed consent form
* FSMC sum score above \> 43 at baseline (mild fatigue)

Key Exclusion Criteria:

* FSMC sum score below 43 at baseline
* History of treatment with Tysabri
* EDSS \> 6 at baseline
* Amphetamine as medication
* Major depression

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: 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.
timeFrame: 0 month and 12 months
Secondary outcomes:
measure: Changes in fatigue after initiation of Tysabri treatment
timeFrame: 3 months, 6 months, 9 months
measure: Change in capacity for work (capacity for work questionnaire (CWQ)) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: Change in health-related-quality of life (HRQ0L) (short form-12 questions (SF-12)) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: Change in Sleepiness (Epworth sleepiness scale (ESS)) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: 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
timeFrame: 0, 6 months, 12 months
measure: Change in depression (Center for epidemiologic studies depression scale (CES-D)) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: Change in Physical activity induced exhaustion (Borg scale CR10 (BS-CR10)) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: Change in speed of walking (6MWT) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: Change in status of MS disease progression (expanded disability status scale (EDSS)) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: Change in amount of walking (step counter) at different points after initiation of Tysabri treatment
timeFrame: 0, 6 months, 12 months
measure: To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression
timeFrame: 6 months, 12 months
measure: To document any changes in fatigue related medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Aarhus
country: Denmark
facility: Research Site
city: Copenhagen
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Bodø
country: Norway
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Førde
country: Norway
facility: Research Site
city: Lillehammer
country: Norway
facility: Research Site
city: Molde
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Danderyd
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Jönköping
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Norrköping
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wickstrom A, Dahle C, Vrethem M, Svenningsson A. Reduced sick leave in multiple sclerosis after one year of natalizumab treatment. A prospective ad hoc analysis of the TYNERGY trial. Mult Scler. 2014 Jul;20(8):1095-101. doi: 10.1177/1352458513517590. Epub 2013 Dec 30.
citation: Svenningsson A, Falk E, Celius EG, Fuchs S, Schreiber K, Berko S, Sun J, Penner IK; Tynergy Trial Investigators. Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting. PLoS One. 2013;8(3):e58643. doi: 10.1371/journal.pone.0058643. Epub 2013 Mar 21.
citation: Penner IK, Sivertsdotter EC, Celius EG, Fuchs S, Schreiber K, Berko S, Svenningsson A; TYNERGY trial investigators. Improvement in Fatigue during Natalizumab Treatment is Linked to Improvement in Depression and Day-Time Sleepiness. Front Neurol. 2015 Feb 23;6:18. doi: 10.3389/fneur.2015.00018. eCollection 2015.