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

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: tight nursing follow-up

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Caen University Hospital
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with tight nursing follow-up; Compared as usual, Patient with tight nursing follow-up will be contacted	Other: tight nursing follow-up; In addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of; 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.; 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
No Intervention: Patient without tight nursing follow-up; Compared as usual, Patient without tight nursing follow-up will not have interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference from baseline of disease activity specific score	The disease activity specific score is DAS28-CRP	Every 3 months during 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference from baseline in quality of life	quality of life will be based on HAQ and SF36 questionnaire	Every 3 months during 2 years
Number of cumulative dose of corticosteroids drugs received		Every 3 months during 2 years
Number of cumulative dose of non-steroidal anti-inflammatory drugs received		Every 3 months during 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Olivier VITTECOQ, Pr, University Hospital, Rouen

Publications and helpful links

General Publications

• 10.4103/2542-4157.248608

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimated): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rituximab; tight monitoring
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: 2015/0190/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No