RecruitingPhase 3NCT04088396

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

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

Sponsor

Eli Lilly and Company

Enrollment

58 participants

Start Date

Feb 12, 2020

Study Type

INTERVENTIONAL

Conditions

Systemic Juvenile Idiopathic Arthritis

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

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Baricitinib and a drug called Tocilizumab for people with systemic juvenile idiopathic arthritis. The study is currently recruiting participants at 55 locations. People eligible for this study include aged 1 Year to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib

Administered orally

DRUGTocilizumab

Administered SC

Locations(55)

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

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, Poland

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Turkey (Türkiye)

9 Eylul University Hospital

Izmir, Turkey (Türkiye)

Bristol Royal Hospital for Children

Bristol, United Kingdom

Alder Hey Children's Hospital

Liverpool, United Kingdom

Great Ormond Street Hospital For Children NHS Foundation Trust

London, United Kingdom

Oxford University Hospitals - Nuffield Orthopaedic Centre

Oxford, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04088396

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