Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants (COSTAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01706107
First received: October 11, 2012
Last updated: July 23, 2015
Last verified: June 2015
  Purpose

The primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS participants over 2 years on the following: annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol 5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2 years.


Condition
Relapsing-Remitting Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.


Secondary Outcome Measures:
  • Change from Baseline in Annualized Relapse Rate [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.

  • Change from Baseline in Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline, Months 12 and 24 ] [ 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 from Baseline in Work Productivity and Activity Impairment [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

  • Change from Baseline in EuroQol 5-Dimension (EQ-5D) [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    The EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety), and a visual analog scale that records the respondent's self-rated health from 0 (worst imaginable health state) to 100 (best imaginable health state).

  • Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    Patient Global Assessment of Wellbeing measures quality of life on a 100 mm Visual Analog Scale (VAS) where 0 is the worst imaginable health state and 100 is the best imaginable health state.

  • Percentage of participants with Clinical Disease-Free Status [ Time Frame: Baseline, Months 12 and 24 ] [ Designated as safety issue: No ]
    Freedom from clinical disease activity is defined as the percentage of participants with no relapse and no EDSS progression, defined as a 1-point change from baseline. 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.


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
  Eligibility

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

Patients who choose to participate in the study will receive a thorough description of the study protocol and an informed consent document describing the study and the risks and benefits of participating. Recruitment will continue until approximately 150 patients have been enrolled in the study at approximately 15 sites across Canada.

Criteria

Key Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
  • Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria).
  • Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
  • Must satisfy the approved therapeutic indications for Tysabri as per Product Monograph.
  • Must either be treatment naïve or have been treated with disease modifying therapy DMT(s) (such as, but not limited to, Avonex, Betaseron, Rebif, Copaxone, Extavia, Tecfidera and/or Gilenya) for ≤5 years total prior to date of informed consent.
  • Decision to treat with Tysabri must precede enrollment.

Key Exclusion Criteria:

  • Any prior treatment with Tysabri.
  • Contraindications to treatment with Tysabri as described in the Product Monograph.
  • History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
  • History of diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS].
  • Receiving immunomodulatory or immunosuppressive therapy.
  • Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab).
  • Immunocompromised at the time of enrollment.
  • Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
  • Women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception.
  • Inability to comply with study requirements.

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: NCT01706107

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
Canada, British Columbia
Vancouver Island Health Authority Recruiting
Victoria, British Columbia, Canada, V8R 1J8
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Dalhousie MS Research Unit Recruiting
Halifax, Nova Scotia, Canada, B3H 4K4
Cape Breton Regional Hospital Recruiting
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
The Ottawa Hospital Completed
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Clinique Neuro-Outaouais Recruiting
Gatineau, Quebec, Canada, J9J 0A5
Neuro Rive-Sud Recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
CHUM - Hopital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Hopital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
McGill University - MNI Recruiting
Montreal, Quebec, Canada, H3A 2B4
CHUS - Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01706107     History of Changes
Other Study ID Numbers: CAN-TYS-12-10333
Study First Received: October 11, 2012
Last Updated: July 23, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Biogen:
Quality of life

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 27, 2015