Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Experienced an adverse drug reaction or not?
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Experienced an adverse drug reaction or not?
时间窗: No specified time frame
次要结局
未报告次要终点
研究者
Bruce Carleton
Principle Investigator
University of British Columbia