Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis (The Treat-JIA)
Treatment Strategies for Juvenile Idiopathic Arthritis Patients With Sustained Inactive Disease: A Phase 4, Multicentre, Randomised Trial Comparing Maintenance Versus Tapered TNF Alpha Inhibitor Monotherapy - the Treat-JIA Trial
The goal of this clinical trial is to learn whether children and adolescents with juvenile idiopathic arthritis (JIA) who have had inactive disease for a long time can safely discontinue treatment with a tumour necrosis factor inhibitor (TNF-inhibitor) monotherapy. The trial compares TNFi withdrawal with continued treatment at a stable dose. The main question it aims to answer is whether TNF-inhibitor withdrawal increases the risk of disease flare during 12 months of follow-up compared with continued treatment. The trial will also assess time to flare, time to regain inactive disease after a flare, changes in disease activity, and the overall safety of both treatment strategies during the same period. Ninety patients aged 2 to 17 years with non-systemic JIA will take part. All study participants will have had inactive disease for at least 12 months while on TNF-inhibitor monotherapy with adalimumab, etanercept or golimumab. Participants will be randomly assigned either to continue their current TNF-inhibitor treatment at a stable dose or to TNF-inhibitor withdrawal. The baseline and follow-up visits up to 12 months will be performed at three hospitals in Norway and include disease activity assessment through joint examination and the Juvenile Arthritis Disease Activity Score (JADAS-27), and where side effects and other health problems are recorded. A flare is defined as a clinically significant increase in disease activity together with at least one active joint, or as agreement between the treating physician and the participant or parents that a flare has occurred.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pernille Bøyesen, MD PhD
- Número de teléfono: +4723070000
- Correo electrónico: boyper@ous-hf.no
Copia de seguridad de contactos de estudio
- Nombre: Siri Hetlevik, MD PhD
- Correo electrónico: siri.opsahl@gmail.com
Ubicaciones de estudio
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Drammen, Noruega
- Drammen Hospital
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Contacto:
- Cathrine Austad, MD PhD
- Número de teléfono: +47 32 80 30 00
- Correo electrónico: cataus@vestreviken.no
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Kristiansand, Noruega
- Hospital of Southern Norway Hospital Trust
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Contacto:
- Hege Høiberg, MD
- Número de teléfono: +47 38 07 30 00
- Correo electrónico: hege.hoiberg@sshf.no
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Oslo, Noruega
- Oslo University Hospital
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Contacto:
- Siri Hetlevik, MD PhD
- Número de teléfono: +4723070000
- Correo electrónico: siri.opsahl@gmail.com
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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:
- Participant must be 2-<18 years of age at the time of signing the informed consent.
- Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic Juvenile Idiopathic Arthritis (JIA).
- Inactive disease for ≥12 months documented at a minimum of 2 consecutive visits and documented inactive disease according to Wallace criteria at inclusion, and no active uveitis for ≥24 months.
- Stable treatment Tumor Necrosis Factor inhibitor (TNFi) monotherapy for ≥ 12 months. Weight adjustments permitted.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Exclusion Criteria:
- Chronic widespread pain syndrome
- Major comorbidity
- Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA less than 12 months prior to randomization.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Stable TNF-inhibitor monotherapy
Continued TNF-inhibitor therapy at a stable dose. This can be adalimumab, etanercept or golimumab. |
Gradual withdrawal of the medication Gradual withdrawal of the medication Gradual withdrawal of the medication Continued stable adalimumab monotherapy Continued stable etanercept monotherapy Continued stable golimumab monotherapy |
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Experimental: TNF-inhibitor withdrawal
Doubled treatment interval of the TNF-inhibitor therapy for 4 months, then subsequent withdraw of the TNF-inhibitor therapy. |
Gradual withdrawal of the medication Gradual withdrawal of the medication Gradual withdrawal of the medication Continued stable adalimumab monotherapy Continued stable etanercept monotherapy Continued stable golimumab monotherapy |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of disease flare
Periodo de tiempo: 4, 8 and 12 months
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Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic treatment. |
4, 8 and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to disease flare
Periodo de tiempo: From enrolment to 12 months follow-up
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Time to disease flare is defined as the time from baseline to the time of disease flare. Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic treatment. |
From enrolment to 12 months follow-up
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Time to regain inactive disease after flare
Periodo de tiempo: From enrolment to 12 months follow-up
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Time to regain inactive disease after flare is defined as the time from disease flare to the time of inactive disease. Disease flare is defined as a combination of: A clinical significant increase in Juvenile Arthritis Disease Activity Score 27 (JADAS-27*) ≥1.7 from baseline AND active joints ≥1 (swollen, or tender + limited range of motion) OR consensus between treating physician and participant/parents that a clinically significant flare has occurred with need of intensification of antirheumatic treatment. Inactive disease is defined according to the Wallace definition: No active arthritis, no active uveitis, no morning stiffness >15 minutes, no systemic features (fever/rash/serositis/splenomegaly/lymphadenopathy due to JIA), a physician global assessment of disease activity 0 on a 0-100 scale) and normalization of C-reactive protien (CRP) and ESR. |
From enrolment to 12 months follow-up
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Incidence of adverse events, serious adverse events and suspected unexpected serious adverse reactions
Periodo de tiempo: From enrolment to 12 months follow-up
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Assessment of AE, serious AE and suspected unexpected serious adverse reactions |
From enrolment to 12 months follow-up
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Physician global assessment of disease activity
Periodo de tiempo: From enrolment to 12 months follow-up
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Physician global assessment of disease activity is measured on a 0-100 mm visual analogue scale (VAS) where higher scores indicate more severe disease. |
From enrolment to 12 months follow-up
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Patient's/parent's global assessment of well-being
Periodo de tiempo: From enrolment to 12 months follow-up
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Patient's/parent's global assessment of well-being will be assessed on a 0-100 mm visual analogue scale where higher scores indicate less well-being. |
From enrolment to 12 months follow-up
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Active joint count
Periodo de tiempo: From enrolment to 12 months follow-up
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68 joints will be evaluated for swelling, 75 joints/joint areas will be evaluated for tenderness and 70 joints/joint areas will be examined for limitation of motion. Range 0-71 with higher scores indicating more joints with arthritis. |
From enrolment to 12 months follow-up
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Erythrocyte sedimentation rate (ESR)
Periodo de tiempo: From enrolment to 12 months follow-up
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Erythrocyte sedimentation rate (ESR) mm/hr |
From enrolment to 12 months follow-up
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Childhood Health Assessment Questionnaire (CHAQ)
Periodo de tiempo: From enrolment to 12 months follow-up
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Childhood Health Assessment Questionnaire (CHAQ) assesses physical function, ranges 0-3 where higher scores indicate better physical function |
From enrolment to 12 months follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pernille Bøyesen, Oslo University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades de la piel y del tejido conectivo
- Artritis Juvenil
- Péptidos
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Receptores, superficie celular
- Proteínas de membrana
- Fragmentos de inmunoglobulina fc
- Fragmentos de inmunoglobulina
- Fragmentos de péptidos
- Regiones constantes de inmunoglobulina
- Receptores, factor de necrosis tumoral
- Receptores, citoquina
- Receptores, inmunológico
- Etanercept
- Adalimumab
- golimumab
Otros números de identificación del estudio
- 2026-525611-13-00
- 2026-525611-13-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Anonymised individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request
Marco de tiempo para compartir IPD
The study protocol and statistical analysis plan will be published as supplementary material to the primary publication.
Criterios de acceso compartido de IPD
Anonymised individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request, following independent assessment of the scientific merit of a predefined research question. Data will be shared through a secure system after approval by the sponsor (Oslo University Hospital) and relevant ethics and data protection authorities, and after a data access agreement has been signed, in accordance with GDPR and Norwegian legislation. The study protocol and statistical analysis plan will be published as supplementary material to the primary publication.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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.
producto fabricado y exportado desde los EE. UU.
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