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

November 6, 2018 updated by: Biogen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Villach, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Denmark
      • Aarhus, Denmark
        • Research Site
      • Copenhagen, Denmark
        • Research Site
      • Odense, Denmark
        • Research Site
  • Norway
      • 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, Norway
        • Research Site
  • Sweden
      • 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
      • Stockholm, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
      • Umeå, Sweden
        • Research Site
      • Örebro, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with Relapsing Remitting Multiple Sclerosis initiating treatment with Tysabri

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Natalizumab
Participants with MS treated with Tysabri over 12 months
Other: Natalizumab
Participants treated with Tysabri
Other Names:
  • Tysabri
  • BG00002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 0 month and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fatigue after initiation of Tysabri treatment
Time Frame: 3 months, 6 months, 9 months
3 months, 6 months, 9 months
Change in capacity for work (capacity for work questionnaire (CWQ)) at different points after initiation of Tysabri treatment
Time Frame: 0, 6 months, 12 months
Capacity for Work Questionnaire (CWQ) is used to collect data regarding number of working hours and sickness absence.
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
Time Frame: 0, 6 months, 12 months
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
Change in Sleepiness (Epworth sleepiness scale (ESS)) at different points after initiation of Tysabri treatment
Time Frame: 0, 6 months, 12 months
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
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
Time Frame: 0, 6 months, 12 months
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
Change in depression (Center for epidemiologic studies depression scale (CES-D)) at different points after initiation of Tysabri treatment
Time Frame: 0, 6 months, 12 months
CES-D is a self-report measure of depression severity.
0, 6 months, 12 months
Change in Physical activity induced exhaustion (Borg scale CR10 (BS-CR10)) at different points after initiation of Tysabri treatment
Time Frame: 0, 6 months, 12 months
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
Change in speed of walking (6MWT) at different points after initiation of Tysabri treatment
Time Frame: 0, 6 months, 12 months
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
Change in status of MS disease progression (expanded disability status scale (EDSS)) at different points after initiation of Tysabri treatment
Time Frame: 0, 6 months, 12 months
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
Change in amount of walking (step counter) at different points after initiation of Tysabri treatment
Time Frame: 0, 6 months, 12 months
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
6 months, 12 months
To document any changes in fatigue related medication
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2009

Primary Completion (ACTUAL)

June 30, 2011

Study Completion (ACTUAL)

June 30, 2011

Study Registration Dates

First Submitted

April 17, 2009

First Submitted That Met QC Criteria

April 17, 2009

First Posted (ESTIMATE)

April 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYNERGY
  • 2008-008065-35 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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