Pharmacogenomics of Drug Safety in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01118130
• Other study ID #: H10-00494
• Status: Recruiting
• Start date: June 2010
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: Bruce Carleton, PharmD
• Phone: 604-875-2179
• Email: bcarleton[@]popi.ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
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	Winnipeg Health Sciences Centre	Winnipeg	Manitoba

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Clinical Genomics Network, Canada Foundation for Innovation, Canadian Institutes of Health Research (CIHR), Genome Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experienced an adverse drug reaction or not?		No specified time frame