Multiple SclerosisNCT01118130
Pharmacogenomics of Drug Safety in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of British Columbia at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 300 participants
- Where
- 5 sitesCanada
- Study dates
- Jun 2010to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- definite MS (Poser or McDonald criteria)
- relapsing-remitting or secondary-progressive disease course
- Prescribed a beta-interferon as their immunomodulatory drug for MS
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Dalhousie MS Research Unit
Halifax, Nova Scotia
London Health Sciences Centre MS clinic
London, Ontario
Hôpital Notre-Dame MS clinic
Montreal, Quebec
MS Clinic UBC Hospital
Vancouver, British Columbia, V6T 2B5
Winnipeg Health Sciences Centre
Winnipeg, Manitoba
About this study
Official title: Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment
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.
Read the 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
- Conditions
- Multiple Sclerosis
- Keywords
- Genetics, genomics, Multiple Sclerosis, beta-interferons
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experienced an adverse drug reaction or not?
Measured: No specified time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2025
- Study completionMay 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canada Foundation for Innovation, Genome Canada, British Columbia Clinical Genomics Network
- Responsible party
- Principal investigator, Bruce Carleton, University of British Columbia
- Investigators
- Bruce Carleton, Principal investigator, University of British ColumbiaMichael Hayden, Study director, University of British ColumbiaHelen Tremlett, Study director, University of British ColumbiaAnthony Traboulsee, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118130
- Sponsor's protocol ID
- H10-00494
- Status last verified
- Jan 2026
- First submitted
- 4 May 2010
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment
- ClinicalTrials.gov ID
- NCT01118130
- Acronym / sponsor ID
- H10-00494
- Conditions
- Multiple Sclerosis
- Keywords
- Genetics, genomics, Multiple Sclerosis, beta-interferons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canada Foundation for Innovation, Genome Canada, British Columbia Clinical Genomics Network
- Study start
- Jun 2010 (actual)
- Primary completion
- May 2025 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- definite MS (Poser or McDonald criteria)
- relapsing-remitting or secondary-progressive disease course
- Prescribed a beta-interferon as their immunomodulatory drug for MS
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experienced an adverse drug reaction or not?
Time frame: No specified time frame
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Carleton principal investigator
University of British Columbia
Michael Hayden study director
University of British Columbia
Helen Tremlett study director
University of British Columbia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of British Columbia at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experienced an adverse drug reaction or not? (time frame: No specified time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.