Clinical trial NCT03027999: Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rituximab
tight monitoring
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Difference from baseline of disease activity specific score
timeFrame: Every 3 months during 2 years
Secondary outcomes:
measure: Difference from baseline in quality of life
timeFrame: Every 3 months during 2 years
measure: Number of cumulative dose of corticosteroids drugs received
timeFrame: Every 3 months during 2 years
measure: Number of cumulative dose of non-steroidal anti-inflammatory drugs received
timeFrame: Every 3 months during 2 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Olivier VITTECOQ, Pr
role: PRINCIPAL_INVESTIGATOR
References: