Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis
12 de noviembre de 2021 actualizado por: Dr. Peter Mandl, Medical University of Vienna
Screening for Flare After Discontinuation of Biological/Targeted Synthetic Disease Modifying Anti-rheumatic Drug (b/tsDMARD) in Rheumatoid Arthritis
To evaluate whether stringent follow-up consisting of combined laboratory and ultrasound surveillance is superior to clinical monitoring alone to maintain clinical remission in rheumatoid arthritis.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Randomized, controlled, parallel-group, multi-centre study in which patients with rheumatoid arthritis treated with biological/targeted synthetic disease modifying antirheumatic drug (b/tsDMARD) in mono- or combination therapy with conventional synthetic disease modifying antirheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months with low disease activity or remission will receive an power Doppler musculoskeletal ultrasound examination (PDUS) and monitoring of C-reactive protein (CRP) levels at baseline and several timepoints within a 24 month study period (primary endpoint) and within a 48 month long-term extension.
At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively.
Further stratification for remission vs. low disease activity and mono- vs combination therapy will be implemented in the randomisation process.
In arm A, CRP and PDUS information will be made available to the clinical assessors who, at each time-point will use this information along with that from clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria.
In arm B the results of CRP and PDUS will be recorded but will not be made available to the clinical assessor who will have to identify clinical flares according to predefined criteria based on information from the clinical examination only.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
85
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Patients with rheumatoid arthritis classified by the American College of Rheumatology/European League Against Rheumatism classification criteria
- biological disease-modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) treatment in monotherapy or in combination therapy with conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months. Previous extension of bDMARD or tsDMARD interval will also be accepted. bDMARDs and tsDMARDs will include all currently available originator and biosimilar compounds, with the exception of rituximab and its biosimilar compounds
- No swollen joint by 28-joint count at baseline, and screening
- C-reactive protein of ≤0.5mg/dL at baseline AND history of C-reactive protein >0,5mg/dl related to rheumatoid arthritis activity
- Clinical disease activity index ≤10
- Shared decision between patient and physician to attempt b/tsDMARD withdrawal
- Willing and able to understand and follow the study procedures
- Written informed consent
- Female and male subjects aged ≥ 18 years
Exclusion Criteria:
- History of or current extra-articular manifestation of rheumatoid arthritis, with exception of rheumatoid nodules
- Systemic glucocorticoid treatment in the past 3 months
- Intraarticular injection with glucocorticoids in the past 1 month
- Joint replacement surgery other than total knee or hip arthroplasty or complete joint destruction
- Power Doppler signal ≥2 in any assessed joint and/or tendon at screening or baseline
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Assisted monitoring
In the Assisted monitoring arm, C-reactive protein and musculoskeletal ultrasound information will be made available to the clinical assessors who, at each time-point will use this information, along with information from the clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria.
|
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
Otros nombres:
|
|
Otro: Clinical monitoring
In the Clinical monitoring arm, the results of C-reactive protein and musculoskeletal ultrasound information will be recorded but will not be made available to the clinical assessor who at each time-point will make the decision on whether the patient is experiencing or has experienced a clinical flare according to predefined criteria based on information from the clinical examination.
|
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of subjects without a clinical flare until week 24
Periodo de tiempo: week 24
|
Proportion of subjects without a clinical flare
|
week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of subjects without a clinical flare
Periodo de tiempo: week 48
|
Proportion of subjects without a clinical flare
|
week 48
|
|
Time to clinical flare (days)
Periodo de tiempo: study period
|
Time to clinical flare (days)
|
study period
|
|
28 swollen joint count
Periodo de tiempo: week 24
|
28 swollen joint count, scale 0 (best) - 28 (worse)
|
week 24
|
|
28 tender joint count
Periodo de tiempo: week 24
|
28 tender joint count, scale 0 (best) - 28 (worse)
|
week 24
|
|
Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation
Periodo de tiempo: week 24
|
Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation
|
week 24
|
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
Periodo de tiempo: week 24
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
|
week 24
|
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
Periodo de tiempo: week 48
|
Proportion of patients in low disease activity or remission based on simplified disease activity index
|
week 48
|
|
Patient's global assessment
Periodo de tiempo: week 24
|
Patient's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
Evaluator's global assessment
Periodo de tiempo: week 24
|
Evaluator's global assessment, scale 0 (best) - 100 (worst)
|
week 24
|
|
C-reactive protein
Periodo de tiempo: week 24
|
C-reactive protein, scale 0 (best) - infinite (worst)
|
week 24
|
|
Radiographic progression
Periodo de tiempo: at week 48 weeks from baseline
|
change in Sharp Van der Heijde score, scale 0 (best) - 488 (worse)
|
at week 48 weeks from baseline
|
|
Health Assessment Questionnaire Disability Index
Periodo de tiempo: week 24
|
Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)
|
week 24
|
|
World Health Organization Quality of Life Questionnaire
Periodo de tiempo: week 24
|
World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)
|
week 24
|
|
Morning stiffness
Periodo de tiempo: week 24
|
Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)
|
week 24
|
|
Fatigue
Periodo de tiempo: week 24
|
Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)
|
week 24
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de marzo de 2022
Finalización primaria (Anticipado)
1 de septiembre de 2024
Finalización del estudio (Anticipado)
1 de septiembre de 2024
Fechas de registro del estudio
Enviado por primera vez
2 de noviembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
12 de noviembre de 2021
Publicado por primera vez (Actual)
15 de noviembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
12 de noviembre de 2021
Última verificación
1 de noviembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Artritis
- Artritis Reumatoide
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Gastrointestinales
- Agentes dermatológicos
- Inhibidores de la proteína quinasa
- Inhibidores del factor de necrosis tumoral
- Etanercept
- Adalimumab
- Infliximab
- Golimumab
- Certolizumab Pegol
- Tofacitinib
- Agentes antirreumáticos
Otros números de identificación del estudio
- 1389/2020
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .