Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse
研究概览
简要总结
This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state.
详细描述
The objective of this multicenter prospective clinical trial is to determine whether ultrasound predicts relapse after discontinuation of infliximab more accurately than does clinical index and to investigate the efficacy and safety of restarting infliximab after relapse in patients with rheumatoid arthritis in remission or low disease activity on infliximab treatment. Infliximab is discontinued in all enrolled patients. Patients are followed up for 48 weeks for monitoring relapse. If relapse occurs, patients receive readministration of infliximab and are further followed up for 24 weeks to determine the efficacy and safety of infliximab readministration. Primary endpoint is the difference in area under curve (AUC) of receiver operator characteristics (ROC) analysis between total power Doppler score and Disease Activity Score (DAS) 28 at baseline to predict relapse within 48 weeks after discontinuation of infliximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Investigators were masked for ultrasound results
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •RA patients who fulfill 2010 ACR/EULAR Classification Criteria
- •Patients who have been treated with infliximab (Remicade) for 26 weeks or longer
- •DAS28 (CRP) < 3.2 at screening
- •Patients who give written informed consent after receiving sufficient information -
排除标准
- •Receiving prednisolone > 10 mg/day
- •Receiving biological or molecular-target anti-rheumatic drug
- •Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit
- •Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit
- •History of infusion reaction to infliximab
- •Current infection which requires treatment
- •Current or previous demyelinating disorder
- •Current congestive heart failure which requires treatment
- •Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period
- •Patients whom investigator or co-investigator consider inappropriate for other reasons -
研究组 & 干预措施
All patients
Discontinue infliximab; Receive infliximab when relapse
干预措施: Infliximab (Drug)
结局指标
主要结局
Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse
时间窗: 48 week
Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab
次要结局
- Change in Health Assessment Questionnaire-Disability Index(48 week)
- EULAR response criteria based on DAS28 after readministration of infliximab(12 week after relapse)
- Area under the ROC curve for total gray-scale score to predict relapse(48 week)
- Number of adverse events as assessed by CTCAE v4.0(Through study completion, an average of 60 weeks)
- Change in van der Heijde modified Sharp score(48 week)
- Change in EuroQoL 5 dimensions-5L(48 week)