The Treat-JIA trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo Universitetssykehus HF

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-06-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

South-Eastern Norway Regional Health Authority

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the effect of treatment withdrawal, compared to stable dose of tumor necrosis factor inhibitor (TNFi), on the risk of flares in children and adolescents with juvenile idiopathic arthritis with sustained inactive disease on TNFi monotherapy for 12 months follow-up*.
*Sustained inactive disease is defined as clinically judged inactive disease for ≥12 months documented at a minimum of 2 consecutive visits AND inactive disease (JIA-ACR/Wallace criteria) at inclusion.

Secondary objectives 3

1. To assess time to flare, and time to regain inactive disease after flare for 12 months follow-up
2. To compare changes in disease activity in the different treatment arms for 12 months follow-up
3. To assess overall safety for 12 months follow-up

Conditions and MedDRA coding

Juvenil Idiopatic Arthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Fulfilment of the ILAR classification criteria for non-systemic JIA; 2 to <18 years of age at the time of signing the informed consent; clinically judged inactive disease for ≥12 months documented at a minimum of 2 consecutive visits; inactive disease (JIA-ACR/Wallace criteria) at inclusion; no active uveitis for ≥24 months; stable treatment with TNF-inhibitor monotherapy for ≥12months.

Exclusion criteria 1

1. Corticosteroid use (including intra-articular injections) at the indication of JIA less than 12 months prior to randomization; chronic widespread pain syndrome.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome of this study is the proportion of study participants with a disease flare* during the first 12 months follow-up compared between the TNFi withdrawal group and the stable treatment group. *Disease flare is defined as a combination of: A clinically significant increase in JIA 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

Secondary endpoints 3

1. Time to flare and time to regain inactive disease after flaring up to 12 months
2. Changes in validated measures of disease activity up to 12 months
3. Reports of adverse events, serious adverse events, and suspected unexpected adverse reactions up to 12 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo Universitetssykehus HF

Sponsor organisation

Oslo Universitetssykehus HF

Address

Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo Universitetssykehus HF

Contact name

Pernille Bøyesen

Public contact point

Organisation

Oslo Universitetssykehus HF

Contact name

Pernille Bøyesen

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications