Rheumatoid Arthritis
Conditions
Keywords
Rituximab, tight monitoring
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
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
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference from baseline of disease activity specific score | Every 3 months during 2 years | The disease activity specific score is DAS28-CRP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference from baseline in quality of life | Every 3 months during 2 years | quality of life will be based on HAQ and SF36 questionnaire |
| 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 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOROlivier VITTECOQ, Pr
University Hospital, Rouen
Outcome results
None listed