Pharmacogenomics of Drug Safety in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT01118130
- Lead Sponsor
- University of British Columbia
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Experienced an adverse drug reaction or not? No specified time frame
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Winnipeg Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Dalhousie MS Research Unit
🇨🇦Halifax, Nova Scotia, Canada
London Health Sciences Centre MS clinic
🇨🇦London, Ontario, Canada
Hôpital Notre-Dame MS clinic
🇨🇦Montréal, Quebec, Canada
MS Clinic UBC Hospital
🇨🇦Vancouver, British Columbia, Canada