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

NCT03027999 | Completed

• 1 other identifier: 2015/0190/HP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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

Conditions

Rheumatoid Arthritis

Keywords

Rituximab; tight monitoring

Outcome Measures

Primary Outcomes (1)

• Difference from baseline of disease activity specific score

  The disease activity specific score is DAS28-CRP

  Every 3 months during 2 years

Secondary Outcomes (3)

• Difference from baseline in quality of life

  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

Study Arms (2)

Patient with tight nursing follow-up

EXPERIMENTAL

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

Other: tight nursing follow-up

Patient without tight nursing follow-up

NO INTERVENTION

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

Interventions

tight nursing follow-up OTHER

In 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

Patient with tight nursing follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (2)

Caen University Hospital

Caen, France

Location

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

• 10.4103/2542-4157.248608

  RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Olivier VITTECOQ, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: May 5, 2017
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)