Relapsing-Remitting Multiple SclerosisTYNERGYNCT00884481
Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS
An observational study of Relapsing-Remitting Multiple Sclerosis and Fatigue, run by Biogen at 27 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis, Fatigue
- What is being tested?
- Natalizumab
- How many people
- 195 participants
- Where
- 27 sitesin 4 countries
- Study dates
- 23 Mar 2009to 30 Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with Relapsing Remitting Multiple Sclerosis initiating treatment with Tysabri
Who may be able to join
- Tysabri prescribed according to national guidelines but not yet started treatment
- Signed informed consent form
- FSMC sum score above > 43 at baseline (mild fatigue)
Who cannot join
- 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
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
Sweden12 sites
Research Site
Danderyd
Research Site
Gothenburg
Research Site
Helsingborg
Research Site
Jönköping
Research Site
Karlstad
Research Site
Lund
Research Site
Malmö
Research Site
Norrköping
Research Site
Örebro
Research Site
Stockholm
Research Site
Trollhättan
Research Site
Umeå
Norway7 sites
Research Site
Bergen
Research Site
Bodø
Research Site
Drammen
Research Site
Førde
Research Site
Lillehammer
Research Site
Molde
Research Site
Oslo
Austria5 sites
Research Site
Graz
Research Site
Innsbruck
Research Site
Salzburg
Research Site
Vienna
Research Site
Villach
Denmark3 sites
Research Site
Aarhus
Research Site
Copenhagen
Research Site
Odense
About this study
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
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.
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Fatigue
- Being tested
- Natalizumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalizumabOther
Also called BG00002, Tysabri
Participants treated with Tysabri
| Study group | Role | What they receive |
|---|---|---|
| Natalizumab | Participants with MS treated with Tysabri over 12 months Receives: Other: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 month and 12 months
Secondary outcomes (12)
Changes in fatigue after initiation of Tysabri treatment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 6 months, 12 months
Change in amount of walking (step counter) at different points after initiation of Tysabri treatment
Measured: 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
Measured: 6 months, 12 months
To document any changes in fatigue related medication
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study start23 Mar 2009
- Primary completion30 Jun 2011
- Study completion30 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884481
- Sponsor's protocol ID
- TYNERGY
- Other IDs
- 2008-008065-35, 2008
- Acronym
- TYNERGY
- Status last verified
- Nov 2018
- First submitted
- 17 Apr 2009
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24378984Svenningsson 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.
PubMed 23555589Penner 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.
PubMed 25755648
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00884481
- Acronym / sponsor ID
- TYNERGY / TYNERGY
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2009 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natalizumab | – | Other: NatalizumabParticipants with MS treated with Tysabri over 12 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with Relapsing Remitting Multiple Sclerosis initiating treatment with Tysabri
Key inclusion criteria (3 listed)
- 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 (6 listed)
- FSMC sum score below 43 at baseline
- History of treatment with Tysabri
- EDSS > 6 at baseline
- Amphetamine as medication
- Major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatalizumabAlso: BG00002, TysabriParticipants treated with Tysabri | Other | Natalizumab |
Primary outcome
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.
12 secondary outcomes
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
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
Time frame: 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
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
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
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
Change in speed of walking (6MWT) at different points after initiation of Tysabri treatment
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Results publication: PubMed 24378984Wickstrom 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.
- Results publication: PubMed 23555589Svenningsson 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.
- Results publication: PubMed 25755648Penner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis and Fatigue, run by Biogen at 27 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Sweden, Norway, Austria, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 0 month and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884481, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.