NCT03757065已完成不适用
A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- ICOS Expression
研究概览
简要总结
This study is designed to explore the expression of cell-surface markers in the following seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g) inflammatory myositis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants 19 years of age or older.
- •Participant or legal surrogate able and willing to provide written, informed consent.
- •Participant is, or has been undergoing care for one of the specified diseases in a participating centre with a confirmed clinical diagnosis of the specified disease.
- •Participant has or will provide the relevant peripheral blood (required) and normal practice tissue specimens (if available).
- •Participant has one of the following target auto-immune or inflammatory diseases diagnosed according to local clinical practice guidelines:
- •Crohn's Disease
- •Inflammatory myositis
- •Multiple sclerosis
- •Sjogren's syndrome
- •Systemic lupus erythematosus
- •Systemic sclerosis
- •Ulcerative colitis
排除标准
- •Participants receiving investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to enrolment.
- •Participants suffering from any additional disease that may interfere with the biomarker signals as per the investigator's discretion.
结局指标
主要结局
ICOS Expression
时间窗: At enrollment
Percentage of ICOS+ T cells in peripheral blood
CD28 Expression
时间窗: At enrollment
Percentage of CD28+ T cells in peripheral blood
次要结局
未报告次要终点
研究者
研究点 (2)
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