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Clinical Trials in the UK / NCT04088396
Active, not recruiting Phase 3

A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

NCT04088396 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2020-02-12
Last updated
2026-08-11

Condition(s) studied

Systemic Juvenile Idiopathic Arthritis

Investigational drug(s) / intervention(s)

BaricitinibTocilizumab

Baricitinib: Administered orally

Tocilizumab: Administered SC

Study summary

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Eligibility

Sex
ALL
Min age
1 Year
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (55)

FacilityCityRegionStatus
Instituto CAICI SRL Rosario Argentina
Centro Medico Privado de Reumatologia SAN M. de Tucuman Argentina
UZ Gent Ghent Belgium
Faculdade de Medicina da UNESP Botucatu Brazil
Hospital de Clinicas de Porto Alegre Porto Alegre Brazil
IPITEC São Paulo Brazil
Universidade Federal de Sao Paulo São Paulo Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP São Paulo Brazil
Detska nemocnice FN Brno Brno Czechia
Vseobecna fakultni nemocnice v Praze Prague Czechia
Hospices Civils de Lyon - Hôpital Femme Mère Enfant Bron France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre Le Kremlin-Bicêtre France
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau Nîmes France
Hôpital Universitaire Necker Enfants Malades Paris France
Centre Hospitalier Universitaire de Poitiers Poitiers France
Sir Ganga Ram Hospital New Delhi India
Meir Medical Center Kfar Saba Israel
Schneider Children's Medical Center Petah Tikva Israel
Sheba Medical Center Ramat Gan Israel
Azienda Ospedaliera Spedali Civili di Brescia Brescia Italy
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti Chieti Italy
IRCCS Istituto Giannina Gaslini Genova Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO Milan Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Italy
University of Naples Federico II Naples Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli Palermo Italy
Ospedale Infantile Burlo Garofolo Trieste Italy
Institute of Science Tokyo Hospital Bunkyō Japan
Chiba Children's Hospital Chiba Japan
Kagoshima University Hospital Kagoshima Japan
Miyagi Children's Hospital Sendai Japan
Osaka Medical and Pharmaceutical University Hospital Takatsuki Japan
Kanagawa Children's Medical Center Yokohama Japan
Yokohama City University Hospital Yokohama Japan
Investigacion y Biomedicina de Chihuahua Chihuahua City Mexico
Instituto de Investigaciones Clínicas para la Salud Durango Mexico
Crea de Guadalajara Guadalajara Mexico
Clinstile, S.A. de C.V. México Mexico
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León Monterrey Mexico
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie Krakow Poland

+ 15 more sites — see the full list on the official registry below.

On this site

📄 Olumiant (baricitinib) drug profile → 📄 Actemra (tocilizumab) drug profile →

More Eli Lilly and Company trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04088396 on ClinicalTrials.gov ↗ ← All trials in the UK