Pharmacogenomics of Drug Safety in Multiple Sclerosis

University of British Columbia

Status

Completed

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT01118130

H10-00494

Details and patient eligibility

About

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.

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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