- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706107
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants (COSTAN)
January 8, 2016 updated by: Biogen
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
73
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Victoria, British Columbia, Canada, V8R 1J8
- Vancouver Island Health Authority
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 4K4
- Dalhousie MS Research Unit
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Sydney, Nova Scotia, Canada, B1P 1P3
- Cape Breton Regional Hospital
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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Toronto, Ontario, Canada, M4N 3M5
- SunnyBrook Health Sciences Centre
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Quebec
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Gatineau, Quebec, Canada, J9J 0A5
- Clinique Neuro-Outaouais
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Greenfield Park, Quebec, Canada, J4V 2J2
- Neuro Rive-Sud
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Montreal, Quebec, Canada, H2L 4M1
- CHUM - Hopital Notre Dame
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Montreal, Quebec, Canada, H3A 2B4
- McGill University - MNI
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Sherbrooke, Quebec, Canada, J1H 5N4
- CHUS - Hôpital Fleurimont
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time Frame: Baseline, Months 12 and 24
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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.
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Baseline, Months 12 and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Annualized Relapse Rate
Time Frame: Baseline, Months 12 and 24
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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.
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Baseline, Months 12 and 24
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Change from Baseline in Expanded Disability Status Scale (EDSS)
Time Frame: Baseline, Months 12 and 24
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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.
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Baseline, Months 12 and 24
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Change from Baseline in Work Productivity and Activity Impairment
Time Frame: Baseline, Months 12 and 24
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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.
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Baseline, Months 12 and 24
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Change from Baseline in EuroQol 5-Dimension (EQ-5D)
Time Frame: Baseline, Months 12 and 24
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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).
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Baseline, Months 12 and 24
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Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale
Time Frame: Baseline, Months 12 and 24
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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.
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Baseline, Months 12 and 24
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Percentage of participants with Clinical Disease-Free Status
Time Frame: Baseline, Months 12 and 24
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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.
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Baseline, Months 12 and 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
October 11, 2012
First Submitted That Met QC Criteria
October 11, 2012
First Posted (Estimate)
October 15, 2012
Study Record Updates
Last Update Posted (Estimate)
January 12, 2016
Last Update Submitted That Met QC Criteria
January 8, 2016
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAN-TYS-12-10333
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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