Pharmacogenomics of Drug Safety in Multiple Sclerosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MS Clinic UBC Hospital, Vancouver, British Columbia, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Experienced an adverse drug reaction or not?

Time frame: No specified time frame

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2025
Study completion: 2025
First posted: May 6, 2010
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed