Pharmacogenomics of Drug Safety in Multiple Sclerosis

Last updated: May 6, 2024
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

N/A

Clinical Study ID

NCT01118130
H10-00494
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 300
Study Start date:
June 01, 2010
Estimated Completion Date:
May 31, 2025

Study 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

Connect with a study center

  • MS Clinic UBC Hospital

    Vancouver, British Columbia V6T 2B5
    Canada

    Active - Recruiting

  • Winnipeg Health Sciences Centre

    Winnipeg, Manitoba
    Canada

    Completed

  • Dalhousie MS Research Unit

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • London Health Sciences Centre MS clinic

    London, Ontario
    Canada

    Site Not Available

  • Hôpital Notre-Dame MS clinic

    Montréal, Quebec
    Canada

    Site Not Available

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