Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2010-06-30
2025-05-31
Brief Summary
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Detailed Description
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OBJECTIVE: To determine whether elevated liver enzyme tests (ALT \> 5 times the upper limit of normal) in response to beta-interferon therapy in MS patients is associated with genetic polymorphisms.
METHOD OF RECRUITMENT:
Patients will be identified through a clinic database and chart reviews. An introductory letter will be mailed to potential participants, inviting them to volunteer. A follow-up phone call will be made to determine interest and consent into study.
PROCEDURES:
Saliva will be collected for genetic analyses and a questionnaire will be administered
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Case
MS patients experiencing an adverse drug reaction to an MS immunomodulatory therapy
No interventions assigned to this group
Control
MS patients not experiencing an adverse drug reaction to an MS immunomodulatory therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* relapsing-remitting or secondary-progressive disease course
* Prescribed a beta-interferon as their immunomodulatory drug for MS
Exclusion Criteria
* an elevated liver test result within 6 months of starting beta-interferon treatment
* presence of a co-morbidity that is a known risk-factor for liver injury
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canada Foundation for Innovation
OTHER
Genome Canada
OTHER
British Columbia Clinical Genomics Network
OTHER
University of British Columbia
OTHER
Responsible Party
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Bruce Carleton
Principle Investigator
Principal Investigators
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Bruce Carleton
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Michael Hayden
Role: STUDY_DIRECTOR
University of British Columbia
Helen Tremlett
Role: STUDY_DIRECTOR
University of British Columbia
Anthony Traboulsee
Role: STUDY_DIRECTOR
University of British Columbia
Locations
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MS Clinic UBC Hospital
Vancouver, British Columbia, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
Dalhousie MS Research Unit
Halifax, Nova Scotia, Canada
London Health Sciences Centre MS clinic
London, Ontario, Canada
Hôpital Notre-Dame MS clinic
Montreal, Quebec, Canada
Countries
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Other Identifiers
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H10-00494
Identifier Type: -
Identifier Source: org_study_id
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