MedPath

Pharmacogenomics of Drug Safety in Multiple Sclerosis

Recruiting
Conditions
Multiple Sclerosis
Registration Number
NCT01118130
Lead Sponsor
University of British Columbia
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.

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

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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
Read More
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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Experienced an adverse drug reaction or not?No specified time frame
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (5)

Winnipeg Health Sciences Centre

🇨🇦

Winnipeg, Manitoba, Canada

Dalhousie MS Research Unit

🇨🇦

Halifax, Nova Scotia, Canada

London Health Sciences Centre MS clinic

🇨🇦

London, Ontario, Canada

Hôpital Notre-Dame MS clinic

🇨🇦

Montréal, Quebec, Canada

MS Clinic UBC Hospital

🇨🇦

Vancouver, British Columbia, Canada

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