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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- 4. fázis
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Pernille Bøyesen, MD PhD
- Telefonszám: +4723070000
- E-mail: boyper@ous-hf.no
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Siri Hetlevik, MD PhD
- E-mail: siri.opsahl@gmail.com
Tanulmányi helyek
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-
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Drammen, Norvégia
- Drammen Hospital
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Kapcsolatba lépni:
- Cathrine Austad, MD PhD
- Telefonszám: +47 32 80 30 00
- E-mail: cataus@vestreviken.no
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Kristiansand, Norvégia
- Hospital of Southern Norway Hospital Trust
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Kapcsolatba lépni:
- Hege Høiberg, MD
- Telefonszám: +47 38 07 30 00
- E-mail: hege.hoiberg@sshf.no
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Oslo, Norvégia
- Oslo University Hospital
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Kapcsolatba lépni:
- Siri Hetlevik, MD PhD
- Telefonszám: +4723070000
- E-mail: siri.opsahl@gmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: 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 |
|
Kísérleti: 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 |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Proportion of disease flare
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Time to disease flare
Időkeret: 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
Időkeret: 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
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Incidence of adverse events, serious adverse events and suspected unexpected serious adverse reactions
Időkeret: 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
Időkeret: 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
Időkeret: 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
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Active joint count
Időkeret: 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)
Időkeret: From enrolment to 12 months follow-up
|
Erythrocyte sedimentation rate (ESR) mm/hr |
From enrolment to 12 months follow-up
|
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Childhood Health Assessment Questionnaire (CHAQ)
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Pernille Bøyesen, Oslo University Hospital
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Mozgásszervi betegségek
- Ízületi gyulladás
- Ízületi betegségek
- Reumás betegségek
- Kötőszöveti betegségek
- Autoimmun betegség
- Immunrendszeri betegségek
- Bőr- és kötőszöveti betegségek
- Ízületi gyulladás, fiatalkorú
- Peptidek
- Aminosavak, peptidek és fehérjék
- Fehérjék
- Antitestek, monoklonális, humanizált
- Antitestek, monoklonális
- Antitestek
- Immunoglobulinok
- Immunoproteinek
- Vérfehérjék
- Szérumglobulinok
- Globulinok
- Receptorok, sejtfelület
- Membránfehérjék
- Immunoglobulin fc fragmensek
- Immunoglobulin fragmensek
- Peptid -fragmensek
- Immunoglobulin állandó régiók
- Receptorok, tumor nekrózis faktor
- Receptorok, citokin
- Receptorok, immunológiai
- Etanercept
- Adalimumab
- golimumab
Egyéb vizsgálati azonosító számok
- 2026-525611-13-00
- 2026-525611-13-00 (Ctis)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Anonymised individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request
IPD megosztási időkeret
The study protocol and statistical analysis plan will be published as supplementary material to the primary publication.
IPD-megosztási hozzáférési feltételek
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.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
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