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

Rheumatoid Arthritis Clinical Trial

— SIERRA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03027999
• Other study ID #: 2015/190/HP
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2017
• Last updated: August 29, 2017
• Start date: May 5, 2017
• Est. completion date: May 2021

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: Deborah LEBEDIEFF, Nurse
• Phone: +3323288
• Email: deborah.lebedieff[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference from baseline of disease activity specific score	The disease activity specific score is DAS28-CRP	Every 3 months during 2 years
Secondary	Difference from baseline in quality of life	quality of life will be based on HAQ and SF36 questionnaire	Every 3 months during 2 years
Secondary	Number of cumulative dose of corticosteroids drugs received		Every 3 months during 2 years
Secondary	Number of cumulative dose of non-steroidal anti-inflammatory drugs received		Every 3 months during 2 years