Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants (COSTAN)
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|ClinicalTrials.gov Identifier: NCT01706107|
Recruitment Status : Terminated (Due to on-going enrollment challenges)
First Posted : October 15, 2012
Last Update Posted : January 12, 2016
|Condition or disease|
|Relapsing-Remitting Multiple Sclerosis|
|Study Type :||Observational|
|Actual Enrollment :||73 participants|
|Official Title:||Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||January 2018|
- Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: Baseline, Months 12 and 24 ]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.
- Change from Baseline in Annualized Relapse Rate [ Time Frame: Baseline, Months 12 and 24 ]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 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706107
|Canada, British Columbia|
|Vancouver Island Health Authority|
|Victoria, British Columbia, Canada, V8R 1J8|
|Canada, New Brunswick|
|Saint John Regional Hospital|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Nova Scotia|
|Dalhousie MS Research Unit|
|Halifax, Nova Scotia, Canada, B3H 4K4|
|Cape Breton Regional Hospital|
|Sydney, Nova Scotia, Canada, B1P 1P3|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5A5|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Gatineau, Quebec, Canada, J9J 0A5|
|Greenfield Park, Quebec, Canada, J4V 2J2|
|CHUM - Hopital Notre Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|McGill University - MNI|
|Montreal, Quebec, Canada, H3A 2B4|
|CHUS - Hopital Fleurimont|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Study Director:||Medical Director||Biogen|