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New pill could ease arthritis in kids – major trial underway

NCT ID NCT04088396

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 6 times

Summary

This study tests whether baricitinib, a daily pill, is safe and works for children aged 1 to under 18 with systemic juvenile idiopathic arthritis (sJIA), a chronic inflammatory disease. About 58 children will receive either baricitinib or a standard injected drug (tocilizumab) to compare results. The goal is to reduce joint inflammation and improve daily life, but ongoing treatment is needed to control the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years * Participants must have at least 2 active joints at screening and baseline * Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age * Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age Exclusion Criteria: * Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis * Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria * Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA * Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis * Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study * Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks * Participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection * Participants must not have a positive test for hepatitis B virus * Participants must not have evidence of active tuberculosis (TB) or untreated latent TB

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Conditions

The condition(s) this trial relates to.

Fever juvenile idiopathic arthritis systemic-onset juvenile idiopathic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic juvenile idiopathic arthritis

Contacts and locations

Locations

  • 9 Eylul University Hospital

    Izmir, 35340, Turkey (Türkiye)

  • Alder Hey Children's Hospital

    Liverpool, L12 2AB, United Kingdom

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

    Chieti, 66100, Italy

  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

    Palermo, 90127, Italy

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ, United Kingdom

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 91-738, Poland

  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021, France

  • Centro Medico Privado de Reumatologia

    SAN M. de Tucuman, T4000AXL, Argentina

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    Milan, 20122, Italy

  • Chiba Children's Hospital

    Chiba, 266-0007, Japan

  • Clinstile, S.A. de C.V.

    México, 06700, Mexico

  • Crea de Guadalajara

    Guadalajara, 44600, Mexico

  • Detska nemocnice FN Brno

    Brno, 613 00, Czechia

  • Faculdade de Medicina da UNESP

    Botucatu, 18618-686, Brazil

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH, United Kingdom

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron, 69500, France

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009, Spain

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León

    Monterrey, 66460, Mexico

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015, France

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • IPITEC

    São Paulo, 01221-020, Brazil

  • IRCCS Istituto Giannina Gaslini

    Genova, 16147, Italy

  • Institute of Science Tokyo Hospital

    Bunkyō, 113-8510, Japan

  • Instituto CAICI SRL

    Rosario, S2000, Argentina

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    São Paulo, 05403-000, Brazil

  • Instituto de Investigaciones Clínicas para la Salud

    Durango, 34000, Mexico

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000, Mexico

  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

    Istanbul, 34098, Turkey (Türkiye)

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • Kanagawa Children's Medical Center

    Yokohama, 232-8555, Japan

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Miyagi Children's Hospital

    Sendai, 989-3126, Japan

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, 02-637, Poland

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686, Japan

  • Ospedale Infantile Burlo Garofolo

    Trieste, 34137, Italy

  • Oxford University Hospitals - Nuffield Orthopaedic Centre

    Oxford, OX3 7HE, United Kingdom

  • Schneider Children's Medical Center

    Petah Tikva, 49202, Israel

  • Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Sheffield Children's Hospital

    Sheffield, S10 2TH, United Kingdom

  • Sir Ganga Ram Hospital

    New Delhi, 110060, India

  • UZ Gent

    Ghent, 9000, Belgium

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-001, Brazil

  • University of Naples Federico II

    Naples, 80131, Italy

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808, Czechia

  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

    Krakow, 31-503, Poland

  • Yokohama City University Hospital

    Yokohama, 236-0004, Japan

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