RecruitingPhase 3NCT03773965

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

Sponsor

Eli Lilly and Company

Enrollment

190 participants

Start Date

Apr 5, 2019

Study Type

INTERVENTIONAL

Conditions

Juvenile Idiopathic Arthritis

Summary

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is an extension trial for children and teenagers (ages 1 to 18) who have already participated in a previous clinical trial testing baricitinib for juvenile idiopathic arthritis (JIA) — a type of chronic arthritis that affects children. Baricitinib is a pill that works by blocking certain signals in the immune system that cause inflammation and joint damage. This extension study allows participants who completed the earlier trial to continue receiving the medication so researchers can learn more about its long-term safety and effectiveness. Juvenile idiopathic arthritis can cause pain, swelling, stiffness, and long-term joint damage in children. Finding treatments that work well and are safe for young patients is an important goal. This study helps researchers understand how well baricitinib continues to work over time and whether it remains safe for children with this condition. You may be eligible if: - Your child is between 1 and 18 years old - Your child has already completed the previous baricitinib JIA study You may NOT be eligible if: - Your child was permanently taken off baricitinib during the previous study - Your child developed an allergy to baricitinib Talk to your doctor to see if this trial is right for you.

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.

Locations(80)

Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova

Moscow, Russia

Scientific Center of Children's Health

Moscow, Russia

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)

Instituto CAICI SRL

Rosario, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Argentina

Royal Children's Hospital

Melbourne, Australia

Perth Children's Hospital

Perth, Australia

The Children's Hospital at Westmead

Westmead, Australia

Landeskrankenhaus Bregenz

Bregenz, Austria

Cliniques universitaires Saint-Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Faculdade de Medicina da UNESP

Botucatu, Brazil

Universidade Federal de Sao Paulo

São Paulo, Brazil

Instituto da Crianca do Hospital das Clinicas da FMUSP

São Paulo, Brazil

Beijing Children's hospital, Capital Medical University

Beijing, China

The Children's Hospital of Chongqing Medical University

Chongqing, China

Childrens Hospital of Nanjing Medical University

Nanjing, China

Children's Hospital of Soochow University

Suzhou, China

Detska nemocnice FN Brno

Brno, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Fakultni nemocnice Motol

Prague, Czechia

Aarhus Universitetshospital, Skejby

Aarhus, Denmark

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

Helios Klinikum Berlin-Buch

Berlin, Germany

Charité Campus Virchow-Klinikum

Berlin, Germany

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Asklepios Klinik Sankt Augustin

Sankt Augustin, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Sri Ramachandra MedicaL College & Research Institute

Chennai, India

Sir Ganga Ram Hospital

New Delhi, India

Christian Medical College Vellore

Vellore, India

Rambam Health Care Campus

Haifa, Israel

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

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

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

Kanazawa University Hospital

Kanazawa, Japan

Niigata University Medical & Dental Hospital

Niigata, Japan

Saitama Children's Medical Center

Saitama-shi, Japan

Miyagi Children's Hospital

Sendai, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, 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. Jose Eleuterio Gonzalez"

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

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NCT03773965

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