Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Counts of patients with epigenetic signatures.
研究概览
简要总结
• Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis patients have been inconclusive. Furthermore the presence of epigenetic signatures in rheumatoid arthritis patients has not been established. This protocol is the first step to identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or medication selection in rheumatoid arthritis patients. Subsequent research into such epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic signatures (EGS) exist the business need for such tests will thus be supported.
详细描述
Two groups of patients will be assessed for the presence unique epigenetic signatures. The test group, having a bonafide diagnosis of rheumatoid arthritis (RA) and a control group of subjects who does not fulfill the American College of Rheumatology's classification criteria for RA. A buccal cell sample and blood draw will be sequenced and analyzed from each subject in each group for the presence of epigenetic signatures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must fulfill the 2010 ACR rheumatoid arthritis classification criteria.
- •Must have at least moderate disease activity (CDAI) for most recent disease activity score
- •Any history of NSAID or corticosteroid use is acceptable
- •Weight at time of blood draw must be greater than 110 lbs.
- •Must be RF+ or CCP+
- •Control patient Inclusion Criteria:
- •Female (age: 18 - 80)
- •Must not fulfill the 2010 ACR rheumatoid arthritis classification criteria.
- •Weight at time of blood draw must be greater than 110 lbs.
- •Age will be within 5 years of a test patient.
排除标准
- •Age 17 or less
- •History of Disease Modifying Anti-Rheumatic Drugs (DMARDs), or biologic DMARDs.
- •History of malignancy, except non-melanoma skin cancer
- •Previous treatment for malignancy with chemotherapy agents
- •Patient reported history of HIV, HepB, HepC, or TB
结局指标
主要结局
Counts of patients with epigenetic signatures.
时间窗: 1 day
The identification of a statistically significant number of RA patients having a consistent epigenetic signature
次要结局
未报告次要终点