Hydroxychloroquine Exposure in Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,700
- 试验地点
- 1
- 主要终点
- Proportion of SLE flares with decrease or discontinuation of HCQ
研究概览
简要总结
A Systemic lupus erythematosus, SLE is disease in which immune system is over-active causing inflammation in joints skin or any organ system. There are many areas where better approaches in SLE could improve outcomes. One example relates to hydroxychloroquine (HCQ) key drug which can reduce risk of serious disease flares. There are increasing concerns about eye damage main side effect with long-term use of HCQ. At present investigators cannot precisely predict which SLE patient is most likely to flare once HCQ is tapered. It is not clear what drives risk of eye damage. Investigators' study will fill these knowledge gaps. Investigators' hypothesis is that baseline demographic and clinical factors are associated with risk of SLE flare after HCQ taper/discontinuation and with risk of retinal toxicity in all HCQ exposed patients. Research will link and analyze data on 3700 SLE patients across Canada.
详细描述
B OBJECTIVES B1 To evaluate in SLE patients who lower but do not discontinue HCQ factors associated with flare (significant increase in disease activity, augmentation of therapy or hospitalization for SLE).
B2 To determine in SLE patients who discontinue HCQ factors associated with flare (significant increase in disease activity, therapy augmentation or hospitalization for SLE).
B3 To evaluate temporal relationship between HCQ use and retinal toxicity in SLE patients and how this may be associated with demographic and clinical factors.
B4 To assess SLE patient preferences for HCQ therapy and how preferences are associated with demographic and clinical factors.
B5 To evaluate temporal relationship between antimalarial use and other forms of toxicity in SLE patients and how this may be associated with demographic and clinical factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Must be 18 years of age or over
- •Must be diagnosed with Systemic Lupus Erythematosus (SLE)
- •Must be exposed to hydroxychloroquine
- •Must be enrolled at participating sites
排除标准
- •Under 18 years of age
- •Not diagnosed with SLE
- •Not exposed to hydroxychloroquine
- •Not enrolled at participating sites
结局指标
主要结局
Proportion of SLE flares with decrease or discontinuation of HCQ
时间窗: Through study completion, an average of 1 year
In patients exposed to HCQ, presence or absence of SLE flare will be measure with SLEDAI-2K. The SLEDAI-2K is a reliable, validated, widely used global score index, consisting of 24 weighted clinical and laboratory variables of nine organ systems. The scores of descriptors range from 1 to 8, and the total score of the SLEDAI-2K is the sum of all 24 descriptor scores. An increase of 4 points or more has been validated as indicating a clinically significant increase in SLE disease activity.
次要结局
- Correlation of retinal toxicity and exposure to HCQ and retinal toxicity(Through study completion, an average of 1 year)
- Proportion of participants hospitalized with decrease or discontinuation of HCQ(Through study completion, an average of 1 year)
- Proportion of SLE flares relative to augmented SLE therapy(Through study completion, an average of 1 year)
研究者
Dr. Sasha Bernatsky
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre