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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

May 4, 2010
May 28, 2014
June 2010
December 2015   (final data collection date for primary outcome measure)
Experienced an adverse drug reaction or not? [ Time Frame: No specified time frame ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01118130 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacogenomics of Drug Safety in Multiple Sclerosis
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.

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

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Saliva

Non-Probability Sample

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.

Multiple Sclerosis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Anne Smith asmith@popi.ubc.ca
Canada
 
NCT01118130
H10-00494
No
University of British Columbia
University of British Columbia
  • Canadian Institutes of Health Research (CIHR)
  • Canada Foundation for Innovation
  • Genome Canada
  • British Columbia Clinical Genomics Network
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
University of British Columbia
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP