Investigating genetic factors affecting liver injury in multiple sclerosis patients on beta-interferon
Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment
This study is trying to find out if certain genetic differences can help explain why some people with multiple sclerosis get liver problems from beta-interferon treatment while others don’t.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 5 sites (Vancouver, British Columbia and 4 other locations) |
| Trial ID | NCT01118130 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify genetic differences between multiple sclerosis (MS) patients who experience liver injury and those who do not while undergoing treatment with beta-interferon. By analyzing saliva samples for genetic polymorphisms and correlating these with liver enzyme levels, the study seeks to uncover potential biomarkers for liver injury risk. Patients will be recruited through clinic databases and will complete a questionnaire alongside genetic testing. The findings could enhance understanding of drug safety in MS treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with definite relapsing-remitting or secondary-progressive multiple sclerosis who are prescribed beta-interferon.
Not a fit: Patients with primary-progressive MS or those with recent elevated liver test results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that minimize the risk of liver injury in MS patients receiving beta-interferon.
How similar studies have performed: While the approach of investigating genetic factors in drug safety is not novel, this specific focus on liver injury in MS patients treated with beta-interferon is relatively untested.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Vancouver, British Columbia and 4 other locations
- MS Clinic UBC Hospital — Vancouver, British Columbia, Canada (Recruiting)
- Winnipeg Health Sciences Centre — Winnipeg, Manitoba, Canada (Completed)
- Dalhousie MS Research Unit — Halifax, Nova Scotia, Canada (Enrolling_by_invitation)
- London Health Sciences Centre MS clinic — London, Ontario, Canada (Enrolling_by_invitation)
- Hôpital Notre-Dame MS clinic — Montréal, Quebec, Canada (Enrolling_by_invitation)
Study contacts
- Principal investigator: Bruce Carleton — University of British Columbia
- Study coordinator: Bruce Carleton, PharmD
- Email: bcarleton@popi.ubc.ca
- Phone: 604-875-2179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.