NCT01118130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

14.9 years

First QC Date

May 4, 2010

Last Update Submit

January 12, 2026

Conditions

Keywords

GeneticsgenomicsMultiple Sclerosisbeta-interferons

Outcome Measures

Primary Outcomes (1)

  • Experienced an adverse drug reaction or not?

    No specified time frame

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • definite MS (Poser or McDonald criteria)
  • relapsing-remitting or secondary-progressive disease course
  • Prescribed a beta-interferon as their immunomodulatory drug for MS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

MS Clinic UBC Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Location

Dalhousie MS Research Unit

Halifax, Nova Scotia, Canada

Location

London Health Sciences Centre MS clinic

London, Ontario, Canada

Location

Hôpital Notre-Dame MS clinic

Montreal, Quebec, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bruce Carleton

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Michael Hayden

    University of British Columbia

    STUDY DIRECTOR
  • Helen Tremlett

    University of British Columbia

    STUDY DIRECTOR
  • Anthony Traboulsee

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 6, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations