Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission (or Low Disease Activity) Under Rituximab to Detect Early Relapse of the Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Difference from baseline of disease activity specific score
研究概览
简要总结
Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium joints and, in the absence of appropriate background therapy, leads to progressive joint destruction, functional, psychological, social and occupational repercussions.
Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to evaluate the therapeutic response to RTX and re-administer it from the 24th week when the goal of remission has not been achieved. However, the optimal modality for reprocessing remains to be determined.
To this end, different approaches have been explored, such as lymphocyte typing or ultrasound monitoring. The pace of these examinations, however, remains wide and their cost is not negligible. This is why we propose here to explore the track of a tight follow-up nurse DAS28.
The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up.
The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Male or female (age 18 or older)
- •Rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria
- •Patient to whom the rheumatologist prescribed a treatment with rituximab or who received a treatment with rituximab in the last 6 months
- •Patients with active rheumatoid arthritis prior to treatment with rituximab (DAS 28 CRP>2.7)
- •Patient with a DAS 28 CRP of less than 2.7 at 6 months from the last administration of rituximab
排除标准
- •Patient not responding to the last treatment with rituximab (DAS28 CRP> 2.7 at 6 months)
- •Patient under the age of 18
- •Patient with chronic pain due to another pathology than rheumatoid arthritis, which may interfere with the assessment
- •Patient with a contraindication to treatment with rituximab
- •Woman of childbearing age not taking effective contraception
- •Pregnant or nursing woman
研究组 & 干预措施
Patient with tight nursing follow-up
Compared as usual, Patient with tight nursing follow-up will be contacted
干预措施: tight nursing follow-up (Other)
Patient without tight nursing follow-up
Compared as usual, Patient without tight nursing follow-up will not have interventions
结局指标
主要结局
Difference from baseline of disease activity specific score
时间窗: Every 3 months during 2 years
The disease activity specific score is DAS28-CRP
次要结局
- Number of cumulative dose of non-steroidal anti-inflammatory drugs received(Every 3 months during 2 years)
- Difference from baseline in quality of life(Every 3 months during 2 years)
- Number of cumulative dose of corticosteroids drugs received(Every 3 months during 2 years)