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Completed

NCT Number: NCT03027999

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tight nursing follow-up

Other

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

Primary outcomes

  1. Difference from baseline of disease activity specific score

    Time frame: Every 3 months during 2 years

    The disease activity specific score is DAS28-CRP

Secondary outcomes

  1. Difference from baseline in quality of life

    Time frame: Every 3 months during 2 years

    quality of life will be based on HAQ and SF36 questionnaire

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study 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

Acronym: SIERRA

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2017
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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