Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pharmacogenomics of Drug Safety in Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of British Columbia
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canada Foundation for Innovation
Genome Canada
British Columbia Clinical Genomics Network
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01118130
First received: May 4, 2010
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Experienced an adverse drug reaction or not? [ Time Frame: No specified time frame ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Saliva


Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118130

Contacts
Contact: Anne Smith asmith@popi.ubc.ca

Locations
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
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Canada Foundation for Innovation
Genome Canada
British Columbia Clinical Genomics Network
Investigators
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01118130     History of Changes
Other Study ID Numbers: H10-00494
Study First Received: May 4, 2010
Last Updated: May 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Genetics
genomics
Multiple Sclerosis
beta-interferons

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014