Clinical trial NCT01118130: Pharmacogenomics of Drug Safety in Multiple Sclerosis
Official title: Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Genetics
genomics
Multiple Sclerosis
beta-interferons
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canada Foundation for Innovation
name: Genome Canada
name: British Columbia Clinical Genomics Network
First posted: 2010-05-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple sclerosis (MS) patients attending MS clinics located at the University of British Columbia Hospital, Winnipeg Health Sciences Centre, Dalhousie (Halifax, Nova Scotia) MS clinic, London Health Sciences Centre (London, ON) and Hôpital Notre-Dame (Montréal). Participants must have definite MS (Poser or McDonald criteria), with a relapsing-remitting or secondary-progressive disease course, registered at one of the above MS Clinics and prescribed a beta-interferon as an immunomodulatory drug for MS.

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

Eligibility 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

Primary outcomes:
measure: Experienced an adverse drug reaction or not?
timeFrame: No specified time frame
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: MS Clinic UBC Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
city: Halifax
country: Canada
facility: Dalhousie MS Research Unit
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre MS clinic
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Notre-Dame MS clinic
state: Quebec
Study officials:
affiliation: University of British Columbia
name: Bruce Carleton
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Michael Hayden
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Helen Tremlett
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Anthony Traboulsee
role: STUDY_DIRECTOR
References: