Pharmacogenomics of Drug Safety in Multiple Sclerosis

January 12, 2026 updated by: Bruce Carleton, University of British Columbia

Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Estimated)

300

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • MS Clinic UBC Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Winnipeg Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Dalhousie MS Research Unit
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre MS clinic
    • Quebec
      • Montreal, Quebec, Canada
        • Hôpital Notre-Dame MS clinic

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 and older (Adult, Older Adult)

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.

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Experienced an adverse drug reaction or not?
Time Frame: No specified time frame
No specified time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)
Canada Foundation for Innovation
Genome Canada
British Columbia Clinical Genomics Network

Investigators

  • 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

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 (Actual)

June 1, 2010

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimated)

May 6, 2010

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-00494

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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