Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in… (NCT03027999) | Clinical Trial Compass
CompletedNot Applicable
Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission
France51 participantsStarted 2017-05-05
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as completed — has the results data been published yet, and if so, what did it show about whether nurse practitioner monitoring worked as well as standard doctor monitoring for RA patients in remission?
2Since this study focused specifically on RA patients who were already in remission, does my current disease activity level match the kind of patients who were enrolled, and is remission even a realistic near-term goal for me?
3The trial measured changes in disease activity scores over time — if the nurse practitioner model proved effective, is that kind of monitoring approach something your practice already uses or could offer me?
4Because this trial had no assigned phase, it was testing a care delivery approach rather than a new drug — how does that affect what my treatment options actually are, and should I be focused more on finding the right medication before thinking about monitoring models like this?
5If tight monitoring by a nurse practitioner is an option, what would that actually look like in my day-to-day life in terms of appointment frequency, what gets checked, and how quickly concerns would be escalated to a rheumatologist?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference from baseline of disease activity specific score