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.

Study Overview

• Status: Not yet recruiting
• Conditions: Juvenile Idiopathic Arthritis (JIA)
• Intervention / Treatment: Drug: Adalimumab; Drug: Etanercept; Drug: Golimumab; Drug: Adalimumab; Drug: Etanercept; Drug: Golimumab

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pernille Bøyesen, MD PhD; Phone Number: +4723070000; Email: boyper@ous-hf.no
• Study Contact Backup: Name: Siri Hetlevik, MD PhD; Email: siri.opsahl@gmail.com

Study Locations

• Norway
  • Drammen, Norway
    • Drammen Hospital
    • Contact: Cathrine Austad, MD PhD; Phone Number: +47 32 80 30 00; Email: cataus@vestreviken.no
  • Kristiansand, Norway
    • Hospital of Southern Norway Hospital Trust
    • Contact: Hege Høiberg, MD; Phone Number: +47 38 07 30 00; Email: hege.hoiberg@sshf.no
  • Oslo, Norway
    • Oslo University Hospital
    • Contact: Siri Hetlevik, MD PhD; Phone Number: +4723070000; Email: siri.opsahl@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant must be 2-<18 years of age at the time of signing the informed consent.
2. Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic Juvenile Idiopathic Arthritis (JIA).
3. 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.
4. Stable treatment Tumor Necrosis Factor inhibitor (TNFi) monotherapy for ≥ 12 months. Weight adjustments permitted.
5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).

Exclusion Criteria:

1. Chronic widespread pain syndrome
2. Major comorbidity
3. Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA less than 12 months prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stable TNF-inhibitor monotherapy; Continued TNF-inhibitor therapy at a stable dose. This can be adalimumab, etanercept or golimumab.	Drug: Adalimumab; Gradual withdrawal of the medication; Drug: Etanercept; Gradual withdrawal of the medication; Drug: Golimumab; Gradual withdrawal of the medication; Drug: Adalimumab; Continued stable adalimumab monotherapy; Drug: Etanercept; Continued stable etanercept monotherapy; Drug: Golimumab; Continued stable golimumab monotherapy
Experimental: TNF-inhibitor withdrawal; Doubled treatment interval of the TNF-inhibitor therapy for 4 months, then subsequent withdraw of the TNF-inhibitor therapy.	Drug: Adalimumab; Gradual withdrawal of the medication; Drug: Etanercept; Gradual withdrawal of the medication; Drug: Golimumab; Gradual withdrawal of the medication; Drug: Adalimumab; Continued stable adalimumab monotherapy; Drug: Etanercept; Continued stable etanercept monotherapy; Drug: Golimumab; Continued stable golimumab monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4, 8 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrolment to 12 months follow-up
Incidence of adverse events, serious adverse events and suspected unexpected serious adverse reactions	Assessment of AE, serious AE and suspected unexpected serious adverse reactions	From enrolment to 12 months follow-up
Physician global assessment of disease activity	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	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	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)	Erythrocyte sedimentation rate (ESR) mm/hr	From enrolment to 12 months follow-up
Childhood Health Assessment Questionnaire (CHAQ)	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Norwegian Rheumatism Association; South-Eastern Norway Regional Health Authority
• Investigators: Principal Investigator: Pernille Bøyesen, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 11, 2026
• Primary Completion (Estimated): November 11, 2029
• Study Completion (Estimated): November 11, 2030

Study Registration Dates

• First Submitted: October 23, 2026
• First Submitted That Met QC Criteria: October 23, 2026
• First Posted (Actual): October 29, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Inactive disease; Non-systemic juvenile idiopathic arthrtitis; TNF-inhibitor monotherapy; Treatment withdrawal
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Juvenile; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Receptors, Cell Surface; Membrane Proteins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Etanercept; Adalimumab; golimumab
• Other Study ID Numbers: 2026-525611-13-00; 2026-525611-13-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Anonymised individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request

IPD Sharing Time Frame

The study protocol and statistical analysis plan will be published as supplementary material to the primary publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes