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