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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Pernille Bøyesen, MD PhD
- Numero di telefono: +4723070000
- Email: boyper@ous-hf.no
Backup dei contatti dello studio
- Nome: Siri Hetlevik, MD PhD
- Email: siri.opsahl@gmail.com
Luoghi di studio
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Drammen, Norvegia
- Drammen Hospital
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Contatto:
- Cathrine Austad, MD PhD
- Numero di telefono: +47 32 80 30 00
- Email: cataus@vestreviken.no
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Kristiansand, Norvegia
- Hospital of Southern Norway Hospital Trust
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Contatto:
- Hege Høiberg, MD
- Numero di telefono: +47 38 07 30 00
- Email: hege.hoiberg@sshf.no
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Oslo, Norvegia
- Oslo University Hospital
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Contatto:
- Siri Hetlevik, MD PhD
- Numero di telefono: +4723070000
- Email: siri.opsahl@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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 |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of disease flare
Lasso di tempo: 4, 8 and 12 months
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to disease flare
Lasso di tempo: From enrolment to 12 months follow-up
|
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
|
|
Time to regain inactive disease after flare
Lasso di tempo: From enrolment to 12 months follow-up
|
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
|
|
Incidence of adverse events, serious adverse events and suspected unexpected serious adverse reactions
Lasso di tempo: From enrolment to 12 months follow-up
|
Assessment of AE, serious AE and suspected unexpected serious adverse reactions |
From enrolment to 12 months follow-up
|
|
Physician global assessment of disease activity
Lasso di tempo: From enrolment to 12 months follow-up
|
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
|
|
Patient's/parent's global assessment of well-being
Lasso di tempo: From enrolment to 12 months follow-up
|
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
|
|
Active joint count
Lasso di tempo: From enrolment to 12 months follow-up
|
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
|
|
Erythrocyte sedimentation rate (ESR)
Lasso di tempo: From enrolment to 12 months follow-up
|
Erythrocyte sedimentation rate (ESR) mm/hr |
From enrolment to 12 months follow-up
|
|
Childhood Health Assessment Questionnaire (CHAQ)
Lasso di tempo: From enrolment to 12 months follow-up
|
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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pernille Bøyesen, Oslo University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Artrite
- Malattie articolari
- Malattie reumatiche
- Malattie del tessuto connettivo
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie della pelle e del tessuto connettivo
- Artrite, giovanile
- Peptidi
- Aminoacidi, peptidi e proteine
- Proteine
- Anticorpi, monoclonali, umanizzati
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Recettori, superficie cellulare
- Proteine della membrana
- Frammenti FC di immunoglobulina
- Frammenti di immunoglobulina
- Frammenti di peptidi
- Regioni costanti di immunoglobulina
- Recettori, fattore di necrosi tumorale
- Recettori, citochine
- Recettori, immunologici
- Etanercept
- Adalimumab
- Golimumab
Altri numeri di identificazione dello studio
- 2026-525611-13-00
- 2026-525611-13-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Anonymised individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request
Periodo di condivisione IPD
The study protocol and statistical analysis plan will be published as supplementary material to the primary publication.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
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prodotto fabbricato ed esportato dagli Stati Uniti
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