Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Functional status
研究概览
简要总结
The correlation of circulating serum miR-125ba and miR-146a expression and clinical response to green tea therapy were analysed in RA patients.Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores. Whereas , a decrease of 1.2 points or above in DAS28 scores at 24 weeks of treatment compared with baseline was defined as clinical response according to the EULAR response criteria.A ready-made solutions containing the primers and probes for human miR-146a and miR-125ba (Applied Biosystems, Foster City, CA) and real-time RT-PCR was estimated using an ABI 7300 system (Applied Bio systems).
详细描述
- participants: A total of 100 subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe activity at the division of rheumatology and clinical immunology at Mansoura University were evaluated in this study.
- patients were evaluated for therapeutic response at baseline and 12, and 24 weeks of green tea therapy. All patients with RA were subjected for estimation of ESR, CRP, disease activity score in 28 joints (DAS28), patient's global assessment (PGA), and health assessment questionnaire damage index (HAQ-DI) at each visits (0 week, 12 weeks, and 24 weeks).
- Pain intensity was assessed by using a standard VAS of 100 mm previously validated to chronic and acute pains.
- Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores.
- human miR-146a and miR-125ba were isolated and subjected to RT-PCR analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe activity at the division of rheumatology and clinical immunology at Mansoura University, between 20 January/2015 and 20 September 2015 were recruited in this prospective study.
- •According to the diagnostic criteria of the American College of Rheumatology (Arnett et al., 1988), all patients classified as showing established RA for more than 8 years.
- •Only patients who had higher scores of DAS28-ESR, RA biomarkers, and established radiographic analysis, and were diagnosed with RA according to the 2010ACR/ EULAR classification criteria were included in this study.
排除标准
- •Patients who received non-steroidal anti-inflammatory drugs, oral glucocorticoids, had a history of severe deformation of joint, pregnant or lactating women were excluded from this study.
结局指标
主要结局
Functional status
时间窗: change from baseline functional status at 24 weeks
It will be assessed using disease activity score -28 (DAS28) and pre-validated health assessment questionnaire damage index (HAQ-DI). For DAS28 score, the number of swelling joints count (SJC) (0-28) and tender joints count (TJC) (0-28) in all patients were examined and DAS28 scores were calculated . DAS28 values \> 2.6 and ≤ 3.2 was considered as low RA disease activity, values \> 3.2 and ≤ 5.1 was considered as moderate disease activity and those \> 5.1 was considered as high disease activity. In case of HAQ-DI, score calculation involves answering of eight domains(dressing, rising, eating, walking, hygiene, grip, reach and usual activities) with four point likert scale . SDAI values \> 3.3 and ≤11 was considered as low RA disease activity, values \> 11 and ≤ 26 was considered as moderate disease activity and those \> 26 was considered as high disease activity
次要结局
- Abnormal cell physiology and the parthenogenesis of Rheumatoid arthritis (RA)(change from baseline functional status at 24 weeks)
- Pain intensity(change from baseline functional status at 24 weeks)
研究者
Sami Gabr
clinical Professor
King Saud University