Pharmacogenomics of Drug Safety in Multiple Sclerosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01118130

Enrollment

300

Registered

2010-05-06

Start date

2010-06-30

Completion date

2025-05-31

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Genetics, genomics, Multiple Sclerosis, beta-interferons

Brief 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.

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Canada

Outcome results