Pharmacogenomics of Drug Safety in Multiple Sclerosis

NCT ID: NCT01118130

Last Updated: 2026-01-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Canada Foundation for Innovation

OTHER

Sponsor Role collaborator

Genome Canada

OTHER

Sponsor Role collaborator

British Columbia Clinical Genomics Network

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Bruce Carleton

Principle Investigator

Responsibility Role PRINCIPAL_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

Site Status

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Dalhousie MS Research Unit

Halifax, Nova Scotia, Canada

Site Status

London Health Sciences Centre MS clinic

London, Ontario, Canada

Site Status

Hôpital Notre-Dame MS clinic

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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H10-00494

Identifier Type: -

Identifier Source: org_study_id

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