Pharmacogenomics of Drug Safety in Multiple Sclerosis

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT01118130

Collaborator

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

300

Enrollment

Locations

155

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Case MS patients experiencing an adverse drug reaction to an MS immunomodulatory therapy
Control MS patients not experiencing an adverse drug reaction to an MS immunomodulatory therapy

Outcome Measures

Primary Outcome Measures

Experienced an adverse drug reaction or not? [No specified time frame]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MS Clinic UBC Hospital	Vancouver	British Columbia	Canada	V6T 2B5
2	Winnipeg Health Sciences Centre	Winnipeg	Manitoba	Canada
3	Dalhousie MS Research Unit	Halifax	Nova Scotia	Canada
4	London Health Sciences Centre MS clinic	London	Ontario	Canada
5	Hôpital Notre-Dame MS clinic	Montréal	Quebec	Canada