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Pharmacogenomics of Drug Safety in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01118130
Recruitment Status : Recruiting
First Posted : May 6, 2010
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canada Foundation for Innovation
Genome Canada
British Columbia Clinical Genomics Network
Information provided by (Responsible Party):
Bruce Carleton, University of British Columbia

Study Description
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Brief Summary:
To investigate whether genotypic differences can be identified between MS patients developing 'liver injury' (defined as ALT levels five times the upper normal limit and above) compared to those not developing liver injury after exposure to beta-interferon for MS.

Condition or disease
Multiple Sclerosis

Detailed Description:

PURPOSE: To investigate whether genotypic differences can be identified between MS patients who develop liver injury compared to those who do not develop injury in response to beta-interferon therapy.

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

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment
Study Start Date : June 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Case
MS patients experiencing an adverse drug reaction to an MS immunomodulatory therapy
Control
MS patients not experiencing an adverse drug reaction to an MS immunomodulatory therapy


Outcome Measures
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Primary Outcome Measures :
  1. Experienced an adverse drug reaction or not? [ Time Frame: No specified time frame ]

Biospecimen Retention:   Samples With DNA
Saliva

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple sclerosis (MS) patients attending MS clinics located at the University of British Columbia Hospital, Winnipeg Health Sciences Centre, Dalhousie (Halifax, Nova Scotia) MS clinic, London Health Sciences Centre (London, ON) and Hôpital Notre-Dame (Montréal). Participants must have definite MS (Poser or McDonald criteria), with a relapsing-remitting or secondary-progressive disease course, registered at one of the above MS Clinics and prescribed a beta-interferon as an immunomodulatory drug for MS.
Criteria

Inclusion Criteria: Cases and controls must have

  • definite MS (Poser or McDonald criteria)
  • relapsing-remitting or secondary-progressive disease course
  • Prescribed a beta-interferon as their immunomodulatory drug for MS

Exclusion Criteria:

  • primary-progressive MS
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01118130


Contacts
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Contact: Bruce Carleton, PharmD 604-875-2179 bcarleton@popi.ubc.ca

Locations
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Canada, British Columbia
MS Clinic UBC Hospital Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Manitoba
Winnipeg Health Sciences Centre Completed
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Dalhousie MS Research Unit Enrolling by invitation
Halifax, Nova Scotia, Canada
Canada, Ontario
London Health Sciences Centre MS clinic Enrolling by invitation
London, Ontario, Canada
Canada, Quebec
Hôpital Notre-Dame MS clinic Enrolling by invitation
Montréal, Quebec, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Canada Foundation for Innovation
Genome Canada
British Columbia Clinical Genomics Network
Investigators
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Principal Investigator: Bruce Carleton University of British Columbia
Study Director: Michael Hayden University of British Columbia
Study Director: Helen Tremlett University of British Columbia
Study Director: Anthony Traboulsee University of British Columbia
More Information
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Responsible Party: Bruce Carleton, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01118130    
Other Study ID Numbers: H10-00494
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by Bruce Carleton, University of British Columbia:
Genetics
genomics
Multiple Sclerosis
beta-interferons
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases