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

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Other: tight nursing follow-up

• Registration Number: NCT03027999
• Lead Sponsor: University Hospital, Rouen

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Study Start: 2017-05-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with tight nursing follow-up	tight nursing follow-up	Compared as usual, Patient with tight nursing follow-up will be contacted

Primary Outcome Measures

Name	Time	Method
Difference from baseline of disease activity specific score	Every 3 months during 2 years	The disease activity specific score is DAS28-CRP

Secondary Outcome Measures

Name	Time	Method
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	quality of life will be based on HAQ and SF36 questionnaire
Number of cumulative dose of corticosteroids drugs received	Every 3 months during 2 years

Trial Locations

Locations (2)

Caen University Hospital; 🇫🇷 Caen, France

Rouen University Hospital; 🇫🇷 Rouen, France