AzTrials
AzTrials

Juvenile Idiopathic Arthritis (JIA)Phase 4The Treat-JIANCT07904780

Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis

A Phase 4 study testing Adalimumab, Etanercept and Golimumab in people with Juvenile Idiopathic Arthritis (JIA), run by Oslo University Hospital at 3 sites in Norway.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Juvenile Idiopathic Arthritis (JIA)
What is being tested?
Adalimumab, Etanercept and Golimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
3 sitesNorway
Study dates
11 Nov 2026to 11 Nov 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pernille Bøyesen, MD PhD contact

+4723070000

boyper@ous-hf.no

Siri Hetlevik, MD PhD contact

siri.opsahl@gmail.com

Norway3 sites

  • Drammen Hospital

    Drammen

    Cathrine Austad, MD PhD, +47 32 80 30 00, cataus@vestreviken.no

  • Hospital of Southern Norway Hospital Trust

    Kristiansand

    Hege Høiberg, MD, +47 38 07 30 00, hege.hoiberg@sshf.no

  • Oslo University Hospital

    Oslo

    Siri Hetlevik, MD PhD, +4723070000, siri.opsahl@gmail.com

Other trials in Norway

About this study

Official title: 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 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.

Being tested
Adalimumab, Etanercept, Golimumab
Keywords
Non-systemic juvenile idiopathic arthrtitis, Inactive disease, TNF-inhibitor monotherapy, Treatment withdrawal
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

    Gradual withdrawal of the medication

  • EtanerceptDrug

    Gradual withdrawal of the medication

  • GolimumabDrug

    Gradual withdrawal of the medication

  • AdalimumabDrug

    Continued stable adalimumab monotherapy

  • EtanerceptDrug

    Continued stable etanercept monotherapy

  • GolimumabDrug

    Continued stable golimumab monotherapy

Study groups in NCT07904780
Study groupRoleWhat they receive
Stable TNF-inhibitor monotherapyActive comparatorContinued TNF-inhibitor therapy at a stable dose. This can be adalimumab, etanercept or golimumab.
Receives: Drug: Adalimumab; Drug: Etanercept; Drug: Golimumab
TNF-inhibitor withdrawalExperimentalDoubled treatment interval of the TNF-inhibitor therapy for 4 months, then subsequent withdraw of the TNF-inhibitor therapy.
Receives: Drug: Adalimumab; Drug: Etanercept; Drug: Golimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4, 8 and 12 months

Secondary outcomes (8)

  1. 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.

    Measured: From enrolment to 12 months follow-up

  2. 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.

    Measured: From enrolment to 12 months follow-up

  3. Safety measures

    Assessment of AE, serious AE and suspected unexpected serious adverse reactions

    Measured: From enrolment to 12 months follow-up

  4. Physician global assessment of disease activity

    Physician global assessment of disease activity is measured on a 100 mm visual analogue scale (VAS).

    Measured: From enrolment to 12 months follow-up

  5. 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.

    Measured: From enrolment to 12 months follow-up

  6. 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.

    Measured: From enrolment to 12 months follow-up

  7. Erythrocyte sedimentation rate (ESR)

    Erythrocyte sedimentation rate (ESR) mm/hr

    Measured: From enrolment to 12 months follow-up

  8. Childhood Health Assessment Questionnaire (CHAQ)

    Physical function

    Measured: From enrolment to 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start11 Nov 2026 (estimated)
  3. Primary completion11 Nov 2029 (estimated)
  4. Study completion11 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904780
Sponsor's protocol ID
2026-525611-13-00
Other IDs
2026-525611-13-00
Acronym
The Treat-JIA
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymised individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalimumab, Etanercept and Golimumab in people with Juvenile Idiopathic Arthritis (JIA), run by Oslo University Hospital at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pernille Bøyesen, MD PhD (+4723070000, boyper@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of disease flare (time frame: 4, 8 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07904780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in