A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

Study Purpose

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including JPsA).
  • - Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).

Exclusion Criteria:

  • - Participants must not have systemic JIA, with or without active systemic features.
  • - Participants must not have persistent oligoarticular arthritis.
  • - Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03773978
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Turkey, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Idiopathic Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Baricitinib Open-Label

Baricitinib given orally.

Experimental: Baricitinib Double Blind

Baricitinib given orally.

Placebo Comparator: Placebo Double Blind

Placebo given orally.

Interventions

Drug: - Baricitinib

Administered orally.

Drug: - Placebo

Administered orally.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Instituto CAICI SRL, Rosario, Santa Fe, Argentina

Status

Recruiting

Address

Instituto CAICI SRL

Rosario, Santa Fe, 2000

Centro Medico Privado de Reumatologia, SAN M. DE Tucuman, Tucuman, Argentina

Status

Recruiting

Address

Centro Medico Privado de Reumatologia

SAN M. DE Tucuman, Tucuman, T4000AXL

Buenos Aires, Argentina

Status

Recruiting

Address

Hospital General de Niños Dr. Pedro de Elizalde

Buenos Aires, , C1270AAN

The Sydney Children's Hospitals Network, Westmead, New South Wales, Australia

Status

Recruiting

Address

The Sydney Children's Hospitals Network

Westmead, New South Wales, 2145

Royal Childrens Hospital Melbourne, Parkville, Victoria, Australia

Status

Recruiting

Address

Royal Childrens Hospital Melbourne

Parkville, Victoria, 3050

Perth Children's Hospital, Nedlands, Western Australia, Australia

Status

Recruiting

Address

Perth Children's Hospital

Nedlands, Western Australia, 6009

LKH Bregenz, Bregenz, Vorarlberg, Austria

Status

Recruiting

Address

LKH Bregenz

Bregenz, Vorarlberg, 6900

AKH, Wien, Austria

Status

Recruiting

Address

AKH

Wien, , 1090

UCL- Saint Luc, Brussels, Brussels-Capital, Belgium

Status

Recruiting

Address

UCL- Saint Luc

Brussels, Brussels-Capital, 1200

UZ Gent-Reuma, Gent, East Flanders, Belgium

Status

Recruiting

Address

UZ Gent-Reuma

Gent, East Flanders, 9000

Leuven, Belgium

Status

Recruiting

Address

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , 3000

CMIP - Centro Mineiro de Pesquisa, Juiz de Fora, Minas Gerais, Brazil

Status

Suspended

Address

CMIP - Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, 36010-570

Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, Brazil

Status

Suspended

Address

Hospital de Clinicas de Porto Alegre

Porto Alegre, RS, 90035-903

Faculdade de Medicina de Botucatu, Botucatu, Sao Paulo, Brazil

Status

Suspended

Address

Faculdade de Medicina de Botucatu

Botucatu, Sao Paulo, 18618-970

Faculdade de Ciências Médicas - UNICAMP, Campinas, Sao Paulo, Brazil

Status

Suspended

Address

Faculdade de Ciências Médicas - UNICAMP

Campinas, Sao Paulo, 13083-887

São Paulo, Brazil

Status

Suspended

Address

Universidade Federal de São Paulo - Escola Paulista de Medicina

São Paulo, , 04038-001

Children's hospital of Nanjing, Nanjing, Jiangsu, China

Status

Recruiting

Address

Children's hospital of Nanjing

Nanjing, Jiangsu, 210008

Chongqing, Tianjin City, China

Status

Recruiting

Address

Children's Hospital of Chongqing Medical University

Chongqing, Tianjin City, 200041

Beijing, China

Status

Recruiting

Address

Capitol Institute of Pediatrics Children'S Hospital

Beijing, , 100020

Beijing, China

Status

Recruiting

Address

Beijing Children's hospital, Capital Medical University

Beijing, , 100045

Suzhou, China

Status

Recruiting

Address

Children's Hospital of Soochow University

Suzhou, , 215025

Prague, Czechia

Status

Recruiting

Address

Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze

Prague, , 121 09

Fakultni Nemocnice v Motole, Praha 5, Czechia

Status

Recruiting

Address

Fakultni Nemocnice v Motole

Praha 5, , 15006

Aarhus Universitetshospital, Skejby, Aarhus, Denmark

Status

Recruiting

Address

Aarhus Universitetshospital, Skejby

Aarhus, , 8200

Paediatric rheumatology Unit, København Ø, Denmark

Status

Recruiting

Address

Paediatric rheumatology Unit

København Ø, , 2100

Bron, France

Status

Recruiting

Address

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, , 69500

Le Kremlin Bicetre, France

Status

Recruiting

Address

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin Bicetre, , 94270

Nîmes, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , 30029

GH Necker - Enfants Malades, Paris Cedex 15, France

Status

Recruiting

Address

GH Necker - Enfants Malades

Paris Cedex 15, , 75743

CHU la Miletrie, Poitiers, France

Status

Recruiting

Address

CHU la Miletrie

Poitiers, , 86000

Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany

Status

Recruiting

Address

Universitätsklinikum Heidelberg

Heidelberg, Baden-Württemberg, 69120

Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany

Status

Recruiting

Address

Universitätsklinikum Tübingen

Tübingen, Baden-Württemberg, 72076

Asklepios Klinik Sankt Augustin, Saint Augustin, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Asklepios Klinik Sankt Augustin

Saint Augustin, Nordrhein-Westfalen, 53757

HELIOS Klinikum Berlin-Buch, Berlin, Germany

Status

Recruiting

Address

HELIOS Klinikum Berlin-Buch

Berlin, , 13125

Charité Campus Virchow-Klinikum, Berlin, Germany

Status

Recruiting

Address

Charité Campus Virchow-Klinikum

Berlin, , 13353

Schön Klinik Hamburg Eilbek, Hamburg, Germany

Status

Recruiting

Address

Schön Klinik Hamburg Eilbek

Hamburg, , 22081

Porur, Chennai, India

Status

Suspended

Address

Sri Ramachandra MedicaL College & Research Institute

Porur, Chennai, 600116

Sir Ganga Ram Hospital, New Delhi, Delhi, India

Status

Recruiting

Address

Sir Ganga Ram Hospital

New Delhi, Delhi, 110060

Christian Medical College Vellore, Vellore, Tamil Nadu, India

Status

Suspended

Address

Christian Medical College Vellore

Vellore, Tamil Nadu, 632 004

Lucknow, Uttar Pradesh, India

Status

Not yet recruiting

Address

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014

Rambam Medical Center, Haifa, Israel

Status

Recruiting

Address

Rambam Medical Center

Haifa, , 3109601

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, , 4428164

Schneider Children's Medical Center, Petah Tiqva, Israel

Status

Recruiting

Address

Schneider Children's Medical Center

Petah Tiqva, , 4920235

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, , 5265601

Ancona, Italy

Status

Recruiting

Address

A.O.U. Ospedali Riuniti- Presidio "G. Salesi" -Reumatologia Pediatrica

Ancona, , 60123

Brescia, Italy

Status

Recruiting

Address

ASST Spedali Civili - Università degli Studi

Brescia, , 25123

Ospedale SS. Annunziata, Chieti, Italy

Status

Recruiting

Address

Ospedale SS. Annunziata

Chieti, , 66100

Azienda Ospedaliero Universitaria Meyer, Firenze, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Meyer

Firenze, , 50139

Genova, Italy

Status

Recruiting

Address

Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

Genova, , 16147

Milano, Italy

Status

Recruiting

Address

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milano, , 20122

Napoli, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Federico II

Napoli, , 80131

Pisa, Italy

Status

Recruiting

Address

Azienda Ospedaliera - Universitaria Pisana

Pisa, , 56126

Ospedale Infantile Burlo Garofolo, Trieste, Italy

Status

Recruiting

Address

Ospedale Infantile Burlo Garofolo

Trieste, , 34137

Kanazawa University Hospital, Kanazawa, Ishikawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital

Kanazawa, Ishikawa, 920 8641

Kanagawa Children's Medical Center, Yokohama, Kanagawa, Japan

Status

Recruiting

Address

Kanagawa Children's Medical Center

Yokohama, Kanagawa, 232-8555

Yokohama City University Hospital, Yokohama, Kanagawa, Japan

Status

Recruiting

Address

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004

Miyagi Children's Hospital, Sendai, Miyagi, Japan

Status

Recruiting

Address

Miyagi Children's Hospital

Sendai, Miyagi, 989-3126

Osaka Medical College Hospital, Takatsuki, Osaka, Japan

Status

Recruiting

Address

Osaka Medical College Hospital

Takatsuki, Osaka, 569-8686

Saitama Children's Medical Center, Saitama-shi, Saitama, Japan

Status

Recruiting

Address

Saitama Children's Medical Center

Saitama-shi, Saitama, 330 8777

Bunkyō, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical And Dental University Medical Hospital

Bunkyō, Tokyo, 113-8519

St. Lukes International Hospital, Chuo-Ku, Tokyo, Japan

Status

Recruiting

Address

St. Lukes International Hospital

Chuo-Ku, Tokyo, 104 8560

Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666

Kagoshima University Hospital, Kagoshima, Japan

Status

Recruiting

Address

Kagoshima University Hospital

Kagoshima, , 890-8520

Niigata, Japan

Status

Recruiting

Address

Niigata University Medical & Dental Hospital

Niigata, , 951-8520

Clinstile, S.A. de C.V., Cuauhtemoc, Federal District, Mexico

Status

Suspended

Address

Clinstile, S.A. de C.V.

Cuauhtemoc, Federal District, 06700

CREA de Guadalajara, S.C., Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

CREA de Guadalajara, S.C.

Guadalajara, Jalisco, 44620

Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

Hospital Univ. "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460

Investigacion y Biomedicina de Chihuahua, Chihuahua, Mexico

Status

Recruiting

Address

Investigacion y Biomedicina de Chihuahua

Chihuahua, , 31000

Durango, Mexico

Status

Recruiting

Address

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, , 34000

Krakow, Poland

Status

Recruiting

Address

Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

Krakow, , 31-503

Lodz, Poland

Status

Recruiting

Address

CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej

Lodz, , 91-738

Warszawa, Poland

Status

Recruiting

Address

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warszawa, , 02-637

Moscow, Russian Federation

Status

Recruiting

Address

V.A. Nasonova Research Institute of Rheumatology

Moscow, , 115522

Moscow, Russian Federation

Status

Recruiting

Address

Morozovsky Children's City Clinical Hospital

Moscow, , 119049

Moscow, Russian Federation

Status

Recruiting

Address

First Moscow State Medical University n.a. Sechenov

Moscow, , 119991

Scientific Center of Children's Health, Moscow, Russian Federation

Status

Recruiting

Address

Scientific Center of Children's Health

Moscow, , 119991

Saint Petersburg, Russian Federation

Status

Suspended

Address

Saint-Petersburg State Pediatric Medical University

Saint Petersburg, , 194100

Hospital Sant Joan de Deu, Barcelona, Cataluna, Spain

Status

Recruiting

Address

Hospital Sant Joan de Deu

Barcelona, Cataluna, 08950

La Coruña, Spain

Status

Recruiting

Address

Complexo Hospitalario Universitario A Coruña, CHUAC

La Coruña, , 15006

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Niño Jesús

Madrid, , 28009

Hospital Universitario Ramón y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal

Madrid, , 28034

Hospital Universitario La Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz

Madrid, , 28046

Hospital Universitario La Fe de Valencia, Valencia, Spain

Status

Recruiting

Address

Hospital Universitario La Fe de Valencia

Valencia, , 46026

Istanbul, Turkey

Status

Recruiting

Address

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , 34098

Dokuz Eylul University Hospital, Izmir, Turkey

Status

Recruiting

Address

Dokuz Eylul University Hospital

Izmir, , 35340

University College Hospital - London, London, Greater London, United Kingdom

Status

Recruiting

Address

University College Hospital - London

London, Greater London, NW1 2PG

Bloomsbury, London, United Kingdom

Status

Recruiting

Address

Great Ormond Street Hospital For Children NHS Foundation Trust

Bloomsbury, London, WC1N 3JH

Sheffield Children's Hospital, Sheffield, South Yorkshire, United Kingdom

Status

Recruiting

Address

Sheffield Children's Hospital

Sheffield, South Yorkshire, S10 2TH

Bristol Royal Hospital for Children, Bristol, United Kingdom

Status

Recruiting

Address

Bristol Royal Hospital for Children

Bristol, , BS2 8BJ

Alder Hey Children's Hospital, Liverpool, United Kingdom

Status

Recruiting

Address

Alder Hey Children's Hospital

Liverpool, , L14 5AB

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