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

NCT ID: NCT03773965

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-05

Study Completion Date

2031-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baricitinib

Baricitinib given orally.

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Administered orally.

Interventions

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Baricitinib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY3009104

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Instituto CAICI SRL

Rosario, , Argentina

Site Status RECRUITING

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, , Argentina

Site Status RECRUITING

Royal Children's Hospital

Melbourne, , Australia

Site Status NOT_YET_RECRUITING

Perth Children's Hospital

Perth, , Australia

Site Status NOT_YET_RECRUITING

The Children's Hospital at Westmead

Westmead, , Australia

Site Status ACTIVE_NOT_RECRUITING

Landeskrankenhaus Bregenz

Bregenz, , Austria

Site Status COMPLETED

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status COMPLETED

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Faculdade de Medicina da UNESP

Botucatu, , Brazil

Site Status RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

IPITEC

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Universidade Federal de Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Instituto da Crianca do Hospital das Clinicas da FMUSP

São Paulo, , Brazil

Site Status RECRUITING

Beijing Children's hospital, Capital Medical University

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

The Children's Hospital of Chongqing Medical University

Chongqing, , China

Site Status ACTIVE_NOT_RECRUITING

Childrens Hospital of Nanjing Medical University

Nanjing, , China

Site Status RECRUITING

Children's Hospital of Soochow University

Suzhou, , China

Site Status RECRUITING

Detska nemocnice FN Brno

Brno, , Czechia

Site Status RECRUITING

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Site Status RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Site Status RECRUITING

Fakultni nemocnice Motol

Prague, , Czechia

Site Status RECRUITING

Aarhus Universitetshospital, Skejby

Aarhus, , Denmark

Site Status RECRUITING

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status RECRUITING

Hôpital Universitaire Necker Enfants Malades

Paris, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status RECRUITING

Helios Klinikum Berlin-Buch

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Charité Campus Virchow-Klinikum

Berlin, , Germany

Site Status COMPLETED

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status COMPLETED

Asklepios Klinik Sankt Augustin

Sankt Augustin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Sri Ramachandra MedicaL College & Research Institute

Chennai, , India

Site Status COMPLETED

Sir Ganga Ram Hospital

New Delhi, , India

Site Status RECRUITING

Christian Medical College Vellore

Vellore, , India

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status RECRUITING

Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Chieti, , Italy

Site Status COMPLETED

IRCCS Istituto Giannina Gaslini

Genova, , Italy

Site Status RECRUITING

Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Milan, , Italy

Site Status NOT_YET_RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status COMPLETED

University of Naples Federico II

Napoli, , Italy

Site Status RECRUITING

Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

Palermo, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Infantile Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

Institute of Science Tokyo Hospital

Bunkyō, , Japan

Site Status RECRUITING

Chiba Children's Hospital

Chiba, , Japan

Site Status RECRUITING

Kagoshima University Hospital

Kagoshima, , Japan

Site Status RECRUITING

Kanazawa University Hospital

Kanazawa, , Japan

Site Status RECRUITING

Niigata University Medical & Dental Hospital

Niigata, , Japan

Site Status RECRUITING

Saitama Children's Medical Center

Saitama-shi, , Japan

Site Status RECRUITING

Miyagi Children's Hospital

Sendai, , Japan

Site Status RECRUITING

Tokyo Women's Medical University Hospital

Shinjuku-ku, , Japan

Site Status RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, , Japan

Site Status RECRUITING

Kanagawa Children's Medical Center

Yokohama, , Japan

Site Status RECRUITING

Yokohama City University Hospital

Yokohama, , Japan

Site Status RECRUITING

Investigacion y Biomedicina de Chihuahua

Chihuahua City, , Mexico

Site Status RECRUITING

Instituto de Investigaciones Clínicas para la Salud

Durango, , Mexico

Site Status RECRUITING

Crea de Guadalajara

Guadalajara, , Mexico

Site Status RECRUITING

Clinstile, S.A. de C.V.

México, , Mexico

Site Status RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, , Mexico

Site Status RECRUITING

Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

Krakow, , Poland

Site Status RECRUITING

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, , Poland

Site Status RECRUITING

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, , Poland

Site Status RECRUITING

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

Moscow, , Russia

Site Status COMPLETED

Scientific Center of Children's Health

Moscow, , Russia

Site Status COMPLETED

Hospital Sant Joan de Déu

Esplugues de Llobregat, , Spain

Site Status RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status RECRUITING

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

9 Eylul University Hospital

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Bristol Royal Hospital for Children

Bristol, , United Kingdom

Site Status RECRUITING

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Site Status RECRUITING

Great Ormond Street Hospital For Children NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Oxford University Hospitals - Nuffield Orthopaedic Centre

Oxford, , United Kingdom

Site Status RECRUITING

Sheffield Children's Hospital

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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Argentina Australia Austria Belgium Brazil China Czechia Denmark France Germany India Israel Italy Japan Mexico Poland Russia Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

1-317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Facility Contacts

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Role: primary

543414248045

Role: primary

+54-381-4200180

Role: primary

61264564348

Role: primary

3216343801

Role: primary

+551438801476

Role: primary

5551999166026

Role: primary

5511 55792581

Role: primary

551126618840

Role: primary

420532234482

Role: primary

420602668887

Role: primary

420727812317

Role: primary

+45 61333138

Role: primary

+33144494828

Role: primary

9727774513

Role: primary

39 091 0916666250

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

526144373003

Role: primary

+52 1 618 812 5351

Role: primary

525552561496

Role: primary

8183338623

Role: primary

+48 126198630

Role: primary

+48426177700

Role: primary

(34)936009733

Role: primary

34 915035900-280

Role: primary

+34961244792

Related Links

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https://trials.lillytrialguide.com/en-US/trial/1jKB0Gb6daw6sUu4gseGga

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

Other Identifiers

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I4V-MC-JAHX

Identifier Type: OTHER

Identifier Source: secondary_id

2017-004471-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16278

Identifier Type: -

Identifier Source: org_study_id

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