A Study of Baricitinib in Participants From 1 Year 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 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.

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 1 Year - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants must have completed a previous study of baricitinib for the treatment of JIA.

Exclusion Criteria:

  • - Participants must not have had a permanent discontinuation of baricitinib in the prior study.
  • - Participants must have not developed an allergy to baricitinib.

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.

NCT03773965
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

Baricitinib given orally.

Interventions

Drug: - Baricitinib

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

Rosario, Santa Fe, Argentina

Status

Recruiting

Address

Instituto Centralizado de Asistencia e Investigacion Clinica

Rosario, Santa Fe, 2000

Hospital Pedro de Elizalde, Buenos Aires, Argentina

Status

Recruiting

Address

Hospital Pedro de Elizalde

Buenos Aires, , C1270AAN

Centro Medico Privado de Reumatologia, Tucuman, Argentina

Status

Recruiting

Address

Centro Medico Privado de Reumatologia

Tucuman, , T4000AXL

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

UZ Gent-Reuma, Gent, East Flanders, Belgium

Status

Recruiting

Address

UZ Gent-Reuma

Gent, East Flanders, 9000

UCL- Saint Luc, Bruxelles, Belgium

Status

Recruiting

Address

UCL- Saint Luc

Bruxelles, , 1200

Leuven, Belgium

Status

Recruiting

Address

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , 3000

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

Status

Not yet recruiting

Address

CMIP - Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, 36010-570

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

Status

Recruiting

Address

Hospital de Clinicas de Porto Alegre

Porto Alegre, RS, 90035-903

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

Status

Not yet recruiting

Address

Faculdade de Medicina de Botucatu

Botucatu, Sao Paulo, 18618-970

Hospital de Clinicas UNICAMP, Campinas, São Paulo, Brazil

Status

Not yet recruiting

Address

Hospital de Clinicas UNICAMP

Campinas, São Paulo, 13083-887

Universidad Federal São Paulo, São Paulo, Brazil

Status

Not yet recruiting

Address

Universidad Federal São Paulo

São Paulo, , 04038-001

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

Status

Recruiting

Address

Children's hospital of Nanjing

Nanjing, Jiangsu, 210008

Suzhou, Jiangsu, China

Status

Not yet recruiting

Address

Children's Hospital of Soochow University

Suzhou, Jiangsu, 210008

Chongqing, Tianjin City, China

Status

Not yet recruiting

Address

Children's Hospital of Chongqing Medical University

Chongqing, Tianjin City, 200041

Beijing, China

Status

Recruiting

Address

Children's Hospital Capital Institute of Pediatrics

Beijing, , 100020

Beijing, China

Status

Recruiting

Address

Beijing Children's hospital, Capital Medical University

Beijing, , 100045

Fakultni Nemocnice v Motole, Praha 5, Motole, Czechia

Status

Recruiting

Address

Fakultni Nemocnice v Motole

Praha 5, Motole, 150 06

Brno, Czechia

Status

Recruiting

Address

Detska nemocnice FN Brno, Ambulance detske revmatologie

Brno, , 613 00

Prague, Czechia

Status

Recruiting

Address

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

Prague, , 121 09

Paediatric rheumatology Unit, København Ø, Denmark

Status

Recruiting

Address

Paediatric rheumatology Unit

København Ø, , 2100

Århus N, Denmark

Status

Recruiting

Address

Center for Børnereumatologi. Børn og Unge

Århus N, , 8200

Hôpital Femme Mère Enfant, Bron, France

Status

Recruiting

Address

Hôpital Femme Mère Enfant

Bron, , 69500

Le Kremlin Bicetre, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Bicetre

Le Kremlin Bicetre, , 94270

CHU de Nimes Hopital Caremeau, Nimes Cedex 9, France

Status

Recruiting

Address

CHU de Nimes Hopital Caremeau

Nimes Cedex 9, , 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

CHU de Nancy Hop D'Enfants de Brabois, Vandoeuvre Les Nancy Cedex, France

Status

Recruiting

Address

CHU de Nancy Hop D'Enfants de Brabois

Vandoeuvre Les Nancy Cedex, , 54511

Universitätsklinikum Freiburg, Freiburg im Breisgau, Baden-Württemberg, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Württemberg, 79106

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

Universitätsklinikum Münster, Münster, Nordrhein-Westfalen, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, 48149

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

Status

Recruiting

Address

Asklepios Klinik Sankt Augustin GmbH

Saint Augustin, Nordrhein-Westfalen, 53757

HELIOS Klinikum Berlin-Buch, Berlin, Germany

Status

Recruiting

Address

HELIOS Klinikum Berlin-Buch

Berlin, , 13125

Charité Universitätsmedizin Berlin, Berlin, Germany

Status

Recruiting

Address

Charité Universitätsmedizin Berlin

Berlin, , 13353

Klinikum Bremen-Mitte, Bremen, Germany

Status

Not yet recruiting

Address

Klinikum Bremen-Mitte

Bremen, , 28205

Universitatsklinikum Dresden, Dresden, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Dresden

Dresden, , 01307

Schön Klinik Hamburg Eilbek, Hamburg, Germany

Status

Recruiting

Address

Schön Klinik Hamburg Eilbek

Hamburg, , 22081

Porur, Chennai, India

Status

Not yet recruiting

Address

SRI Ramachandra Medical College and Hospital

Porur, Chennai, 600116

Sir Ganga Ram Hospital, New Delhi, Delhi, India

Status

Not yet recruiting

Address

Sir Ganga Ram Hospital

New Delhi, Delhi, 110060

Christian Medical College and Hospital, Vellore, Tamil Nadu, India

Status

Not yet recruiting

Address

Christian Medical College and Hospital

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 Medical Center, Petah Tiqva, Israel

Status

Recruiting

Address

Schneider Medical Center

Petah Tiqva, , 4920235

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, , 5265601

Milano, Lombardia, Italy

Status

Not yet recruiting

Address

Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Milano, Lombardia, 20122

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

A.O.Universitaria Meyer, Firenze, Italy

Status

Recruiting

Address

A.O.Universitaria Meyer

Firenze, , 50139

Genova, Italy

Status

Recruiting

Address

Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini - Reumatologia Pediatrica

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 Bambino Gesu, Roma, Italy

Status

Not yet recruiting

Address

Ospedale Bambino Gesu

Roma, , 00165

Istituto Burlo Garofolo, Trieste, Italy

Status

Recruiting

Address

Istituto Burlo Garofolo

Trieste, , 34137

Kanazawa University Hospital, Kanazawa, Ishikawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital

Kanazawa, Ishikawa, 920 8641

Yokohama, Kanagawa, Japan

Status

Recruiting

Address

Kanagawa Prefectural Childrens 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-shi, Miyagi, Japan

Status

Recruiting

Address

Miyagi Children's Hospital

Sendai-shi, 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

Bunkyo-ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical And Dental University Hospital

Bunkyo-ku, Tokyo, 113-8519

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

Status

Recruiting

Address

St. Lukes International Hospital

Chuo-Ku, Tokyo, 104 8560

Chiba Children's Hospital, Chiba, Japan

Status

Recruiting

Address

Chiba Children's Hospital

Chiba, , 266-0007

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

Recruiting

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

Chihuahua, Mexico

Status

Recruiting

Address

Investigación y Biomedicina de Chihuahua, SC

Chihuahua, , 31000

Durango, Mexico

Status

Recruiting

Address

Instituto de Investigaciones Clínicas para la Salud

Durango, , 34000

Krakow, Poland

Status

Recruiting

Address

Szpital Dzieciecy Sw. Ludwika Oddzial Reumatologii

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

Morozov Children's City Hospital, Moscow, Russian Federation

Status

Recruiting

Address

Morozov Children's City Hospital

Moscow, , 119049

Center of Children`s Health, Moscow, Russian Federation

Status

Recruiting

Address

Center of Children`s Health

Moscow, , 119991

Moscow, Russian Federation

Status

Recruiting

Address

First Moscow State Medical University n.a. Sechenov

Moscow, , 119991

Saint-Petersburg, Russian Federation

Status

Recruiting

Address

St. 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

Hospital Infantil Niño Jesus, Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Niño Jesus

Madrid, , 28009

Hospital Universitario Ramon y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramon y Cajal

Madrid, , 28034

Hospital Universitario La Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz

Madrid, , 28046

Hospital Universitario Virgen del Rocio, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen del Rocio

Sevilla, , 41013

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-Department of pediatric Rheumatology

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

Great Ormond Street Hospital, Bloomsbury, London, United Kingdom

Status

Recruiting

Address

Great Ormond Street Hospital

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

Leeds Children's Hospital, Leeds, United Kingdom

Status

Not yet recruiting

Address

Leeds Children's Hospital

Leeds, , LS2 9NS

Alder Hey Children's Hospital, Liverpool, United Kingdom

Status

Recruiting

Address

Alder Hey Children's Hospital

Liverpool, , L14 5AB

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