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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00884481
First received: April 17, 2009
Last updated: July 9, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Relapsing-Remitting Multiple Sclerosis
Fatigue
Other: Natalizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes in fatigue after initiation of Tysabri treatment [ Time Frame: 3 months, 6 months, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Capacity for Work Questionnaire (CWQ) is used to collect data regarding number of working hours and sickness absence.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change in Sleepiness (Epworth sleepiness scale (ESS)) at different points after initiation of Tysabri treatment [ Time Frame: 0, 6 months, 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    CES-D is a self-report measure of depression severity.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change in speed of walking (6MWT) at different points after initiation of Tysabri treatment [ Time Frame: 0, 6 months, 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change in amount of walking (step counter) at different points after initiation of Tysabri treatment [ Time Frame: 0, 6 months, 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To document any changes in fatigue related medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Natalizumab
Participants with MS treated with Tysabri over 12 months
Other: Natalizumab
Participants treated with Tysabri
Other Names:
  • BG00002
  • Tysabri

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects diagnosed with Relapsing Remitting Multiple Sclerosis initiating treatment with Tysabri

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884481

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided by Biogen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00884481     History of Changes
Obsolete Identifiers: NCT00966797
Other Study ID Numbers: 2008-008065-35
Study First Received: April 17, 2009
Last Updated: July 9, 2015
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Fatigue
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2015