Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS

Fatigue Clinical Trial

— TYNERGY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884481
• Other study ID #: TYNERGY
• Secondary ID: 2008-008065-35
• Status: Completed
• Start date: March 23, 2009
• Est. completion date: June 30, 2011

Study information

• Verified date: November 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00966797

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: June 30, 2011
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Natalizumab
Participants treated with Tysabri

Locations

Country	Name	City	State
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Salzburg
Austria	Research Site	Villach
Austria	Research Site	Wien
Denmark	Research Site	Aarhus
Denmark	Research Site	Copenhagen
Denmark	Research Site	Odense
Norway	Research Site	Bergen
Norway	Research Site	Bodø
Norway	Research Site	Drammen
Norway	Research Site	Førde
Norway	Research Site	Lillehammer
Norway	Research Site	Molde
Norway	Research Site	Oslo
Sweden	Research Site	Danderyd
Sweden	Research Site	Göteborg
Sweden	Research Site	Helsingborg
Sweden	Research Site	Jönköping
Sweden	Research Site	Karlstad
Sweden	Research Site	Lund
Sweden	Research Site	Malmö
Sweden	Research Site	Norrköping
Sweden	Research Site	Örebro
Sweden	Research Site	Stockholm
Sweden	Research Site	Trollhättan
Sweden	Research Site	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Austria,  Denmark,  Norway,  Sweden, 

References & Publications (3)

Penner IK, Sivertsdotter EC, Celius EG, Fuchs S, Schreiber K, Berkö 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 — View Citation

Svenningsson A, Falk E, Celius EG, Fuchs S, Schreiber K, Berkö 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; — View Citation

Wickström 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 month and 12 months
Secondary	Changes in fatigue after initiation of Tysabri treatment		3 months, 6 months, 9 months
Secondary	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.	0, 6 months, 12 months
Secondary	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.	0, 6 months, 12 months
Secondary	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.	0, 6 months, 12 months
Secondary	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).	0, 6 months, 12 months
Secondary	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.	0, 6 months, 12 months
Secondary	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.	0, 6 months, 12 months
Secondary	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.	0, 6 months, 12 months
Secondary	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.	0, 6 months, 12 months
Secondary	Change in amount of walking (step counter) at different points after initiation of Tysabri treatment		0, 6 months, 12 months
Secondary	To investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of MS disease progression		6 months, 12 months
Secondary	To document any changes in fatigue related medication		12 months