Pharmacogenomics of Drug Safety in Multiple Sclerosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01118130 |
Recruitment Status :
Recruiting
First Posted : May 6, 2010
Last Update Posted : June 1, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Multiple Sclerosis |
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 Type : | Observational |
Estimated 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 : | June 2010 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | May 2023 |

Group/Cohort |
---|
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
|
- Experienced an adverse drug reaction or not? [ Time Frame: No specified time frame ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118130
Contact: Bruce Carleton, PharmD | 604-875-2179 | bcarleton@popi.ubc.ca |
Canada, British Columbia | |
MS Clinic UBC Hospital | Recruiting |
Vancouver, British Columbia, Canada, V6T 2B5 | |
Canada, Manitoba | |
Winnipeg Health Sciences Centre | Completed |
Winnipeg, Manitoba, Canada | |
Canada, Nova Scotia | |
Dalhousie MS Research Unit | Enrolling by invitation |
Halifax, Nova Scotia, Canada | |
Canada, Ontario | |
London Health Sciences Centre MS clinic | Enrolling by invitation |
London, Ontario, Canada | |
Canada, Quebec | |
Hôpital Notre-Dame MS clinic | Enrolling by invitation |
Montréal, Quebec, Canada |
Principal Investigator: | Bruce Carleton | University of British Columbia | |
Study Director: | Michael Hayden | University of British Columbia | |
Study Director: | Helen Tremlett | University of British Columbia | |
Study Director: | Anthony Traboulsee | University of British Columbia |
Responsible Party: | Bruce Carleton, Principle Investigator, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT01118130 |
Other Study ID Numbers: |
H10-00494 |
First Posted: | May 6, 2010 Key Record Dates |
Last Update Posted: | June 1, 2022 |
Last Verified: | May 2022 |
Genetics genomics Multiple Sclerosis beta-interferons |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |