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

University Hospital, Rouen

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: tight nursing follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03027999

2015/0190/HP

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Patient with tight nursing follow-up

Experimental group

Description:

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

Treatment:

Other: tight nursing follow-up

Patient without tight nursing follow-up

No Intervention group

Description:

Compared as usual, Patient without tight nursing follow-up will not have interventions