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Pharmacogenomics of Drug Safety in Multiple Sclerosis

Pharmacogenomics of Drug Safety in Multiple Sclerosis

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Eligibility

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 details
    Multiple Sclerosis

NCT01118130

University of British Columbia

14 May 2024

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