Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission (SIERRA)
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
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Caen, Francia
- Reclutamiento
- Caen University Hospital
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Contacto:
- Christian MARCELLI, Pr
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Investigador principal:
- Christian MARCELLI, Pr
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Rouen, Francia
- Reclutamiento
- Rouen University hospital
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Investigador principal:
- Olivier VITTECOQ, Pr
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Contacto:
- Deborah LEBEDIEFF
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Patient with tight nursing follow-up
Compared as usual, Patient with tight nursing follow-up will be contacted
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In addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of
|
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Sin intervención: Patient without tight nursing follow-up
Compared as usual, Patient without tight nursing follow-up will not have interventions
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference from baseline of disease activity specific score
Periodo de tiempo: Every 3 months during 2 years
|
The disease activity specific score is DAS28-CRP
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Every 3 months during 2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference from baseline in quality of life
Periodo de tiempo: Every 3 months during 2 years
|
quality of life will be based on HAQ and SF36 questionnaire
|
Every 3 months during 2 years
|
|
Number of cumulative dose of corticosteroids drugs received
Periodo de tiempo: Every 3 months during 2 years
|
Every 3 months during 2 years
|
|
|
Number of cumulative dose of non-steroidal anti-inflammatory drugs received
Periodo de tiempo: Every 3 months during 2 years
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Every 3 months during 2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Olivier VITTECOQ, Pr, Rouen University hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015/190/HP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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