Assessing the Role of the NLRP3 Inflammasome in Driving Inflammation in Affected Joints of Patients With Intercritical Gout
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- IL-1B Role in Driving Inflammation in Intercritical Gout
研究概览
简要总结
Gout is an autoinflammatory disease characterized by flares of painful joint inflammation. This inflammation occurs in response to uric acid that crystallizes. After a gout attack, patients usually enter a period that is accompanied by low grade inflammation but is otherwise relatively asymptomatic. Gout is typically associated with certain markers, and this study is going describe specific markers in patients that are in between gout attacks. Research has been focused on studying this phase between gout attacks in hopes to manage and prevent the onset of future gout attacks. Biopsies will be taken from the affected joint and blood will be drawn from patients who are currently in between gout attacks. This work will provide important information regarding how crystals in the joint lining are associated with chronic inflammation in the periods between gout attacks. Moreover, this study will identify novel biomarkers that may be useful in determining the severity of disease activity through a blood test.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with gout diagnosed by a Rheumatologist.
- •patients with a history of at least two gout attacks in the target joint
- •Patients with a target joint amenable to biopsy. Target joint defined as:
- •Joint that has been affected by acute gout attack at least twice in the 12 months prior to enrollment.
- •Ultrasound finds grade 2 gray-scale synovitis in joint. Joint is amenable to biopsy. At the time of enrollment, the joint is without signs of acute inflammation: redness, swelling, and severe pain (>7/10).
排除标准
- •Patients on anti-coagulation therapy.
- •Patients with an active infection.
- •Tophus present at the biopsy site.
- •Target joint with signs of acute gout attack (pain >7/10, redness, warmth)
- •Known chondrocalcinosis
结局指标
主要结局
IL-1B Role in Driving Inflammation in Intercritical Gout
时间窗: Up to 2 months
Examine the role of IL-1b in driving inflammation within intercritical gout via the measurement of IL-1b levels. IL-1b concentration levels (physiological parameter) will be measured in ng/ml.
NLRP3 Inflammasome Role in Driving Inflammation in Intercritical Gout
时间窗: Up to 2 months
To investigate the role of the NLRP3 inflammasome in driving inflammation in intercritical gout. Specifically, this will be accomplished via measuring caspase-1 activity as a marker of inflammasome activity. We will measure the % of patients who show a %positivity (physiological parameter) of caspase-1 activity.
次要结局
- Immune Cell Infiltration in the Inflamed Joint Correlation(Up to 2 months)
- Uric Acid Levels Correlation(Up to 2 months)
- Microcrystal Correlation(Up to 2 months)
研究者
Swamy Venuturupalli
Founder of Attune Health, Attending Rheumatologist at Cedar Sinai Medical Center, Associate Clinical Professor of Medicine at UCLA
Attune Health Research, Inc.