on-steroidal anti-inflammatory drug Discontinuation study on Disease stable Rheumatoid arthritis patients
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
Among 109 enrolled patients, 105 completed the 16-week follow-up. Eighty-nine (84.8%) patients remained without restarting NSAIDs. In these patients, there was a slight increase in their pain levels compared with baseline (median 14.0 versus 19.0 using the pain-visual analog scale, p = 0.010). However, changes in DAS28-ESR (p = 0.638) and routine assessment of patient index data 3 (RAPID-3) (p = 0.128) were insignificant. Moreover, 66 (62.9%) patients showed sustained effectiveness on PRO without restarting NSAIDs. In the multivariate regression models, joint swelling was the detrimental factor in NSAID withdrawal (odds ratio [OR] 0.149, 95% confidence interval [CI] 0.033–0.680, p = 0.014) and sustained effectiveness (OR 0.284, 95% CI 0.091–0.883, p = 0.030). Joint pain in RA patients in remission or with LDA can be well managed without NSAIDs, especially in those without swollen joints at the time of cessation.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- o Limit 至 o Limit（—）
- 性别
- All
入选标准
- •1) Patients with RA who fulfill the 1987 ACR classification criteria for RA and diagnosed at least 6 months before enrollment.
- •2) DAS28-ESR < 3.2 in two consecutive examinations apart for at least 1 month
- •3) Regularly taking any type of NSAID for more than 4 weeks (irrespective of dose)
- •4)Patient who take regularly takes less than 7.5mg of oral steroids over a month.
- •5)Patients who understand about the study, and provided informed consent
排除标准
- •1) Patients enrolled in other phase 1,2,3 clinical trials.
- •2) Patients who had any type of adverse effects of acetaminophen (Patients who has elevated AST/ALT levels more than 2 times of upper normal range of reference value)
- •3) Patients with concurrent fibromyalgia or severe osteoarthritis with Kellgren grade III/IV