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CompletedNCT03027999SIERRAUpdated Apr 16, 2026

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

An interventional study of tight nursing follow-up in Rheumatoid Arthritis, sponsored by University Hospital, Rouen. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rituximab
  • tight monitoring
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 51 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Patient with tight nursing follow-up

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

    Other: tight nursing follow-up

  • No intervention
    Patient without tight nursing follow-up

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

Interventions

  • Othertight nursing follow-up

    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

06

What researchers measure

Primary outcomes

  1. Difference from baseline of disease activity specific score

    The disease activity specific score is DAS28-CRP

    Time frame: Every 3 months during 2 years

Secondary outcomes

  1. Difference from baseline in quality of life

    quality of life will be based on HAQ and SF36 questionnaire

    Time frame: Every 3 months during 2 years

  2. Number of cumulative dose of corticosteroids drugs received

    Time frame: Every 3 months during 2 years

  3. Number of cumulative dose of non-steroidal anti-inflammatory drugs received

    Time frame: Every 3 months during 2 years

07

Study locations

2 sites
  • Caen University Hospital
    Caen, France
  • Rouen University Hospital
    Rouen, France
08

References and documents

Publications

  • 10.4103/2542-4157.248608

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03027999
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Jan 23, 2017
Start date
May 5, 2017
Primary completion
Sep 22, 2022
Completion
Sep 22, 2022
Last update
Apr 16, 2026

Study contacts

Olivier VITTECOQ, Pr
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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