A Phase 4 interventional study of Adalimumab and Etanercept in Juvenile Idiopathic Arthritis (JIA), sponsored by Oslo University Hospital. Not yet recruiting at 3 sites in Norway. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment
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 of them 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. They will be followed for 12 months at three hospitals in Norway, with regular visits where disease activity is assessed 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.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 90 is above the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continued TNF-inhibitor therapy at a stable dose. This can be adalimumab, etanercept or golimumab.
Drug: Adalimumab · Drug: Etanercept · Drug: Golimumab
Doubled treatment interval of the TNF-inhibitor therapy for 4 months, then subsequent withdraw of the TNF-inhibitor therapy.
Drug: Adalimumab · Drug: Etanercept · Drug: 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
Proportion 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.
Time frame: 4, 8 and 12 months
Time to disease flare
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.
Time frame: From enrolment to 12 months follow-up
Time to regain inactive disease after flare
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.
Time frame: From enrolment to 12 months follow-up
Safety measures
Assessment of AE, serious AE and suspected unexpected serious adverse reactions
Time frame: From enrolment to 12 months follow-up
Physician global assessment of disease activity
Physician global assessment of disease activity is measured on a 100 mm visual analogue scale (VAS).
Time frame: From enrolment to 12 months follow-up
Patient's/parent's global assessment of well-being
Patient's/parent's global assessment of well-being will be assessed on a 100 mm visual analogue scale.
Time frame: From enrolment to 12 months follow-up
Active joint count
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.
Time frame: From enrolment to 12 months follow-up
Erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (ESR) mm/hr
Time frame: From enrolment to 12 months follow-up
Childhood Health Assessment Questionnaire (CHAQ)
Physical function
Time frame: From enrolment to 12 months follow-up
Plan to share: Yes — Anonymised individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request
Supporting information: Study protocol, Statistical analysis plan
Time frame: The study protocol and statistical analysis plan will be published as supplementary material to the primary publication.
Access criteria: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Adalimumab · Etanercept · Golimumab