Clinical Trials Directory

Trials / Completed

CompletedNCT03027999

Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHERtight nursing follow-upIn addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of 1. a training session to self-assess their RA: Self-assessment of the number of painful and swollen joints, of pain and disease activity (global assessment by the patient) (self-DAS). During this session, a scheduled dosage of ESR and CRP levels will be given to the patient. 2. A monthly call by a nurse who inquires about the results of the patient's self-assessment. As soon as she suspects a relapse of RA, she plans a consultation to confirm or not the relapse. For this purpose, she calculates the DAS28 taking into account the results of the biological test, the articular count and the disease activity. Clinical relapse is documented by a DAS28-CRP \> 2.7

Timeline

Start date
2017-05-05
Primary completion
2022-09-22
Completion
2022-09-22
First posted
2017-01-23
Last updated
2026-04-16

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03027999. Inclusion in this directory is not an endorsement.