Actively Recruiting

Phase 3

Age: 1Year - 18Years

All Genders

ID03773965

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

Led by Eli Lilly and Company

- Updated on 2026-05-12

190

Participants Needed

80

Research Sites

N/A

Total Duration

On this page

AI-Summary

Brief Title

Who Can Participate

AI-Screening

Your Study Journey

Trial Site Locations

Research Team

How is the study designed?

Similar Trials

Frequently Asked Questions

AI-Summary

What This Trial Is About

Researchers are evaluating the long-term safety and effectiveness of the drug baricitinib for treating Juvenile Idiopathic Arthritis JIA in children and adolescents aged 1 to less than 18 years. This Phase 3 study focuses on participants who have previously taken part in baricitinib studies for JIA. The goal is to understand how well baricitinib works and monitor any serious side effects over an extended period. Participants will receive baricitinib orally as part of the study treatment. The study tracks outcomes such as the frequency of serious adverse events, permanent discontinuations of the drug, and various measures of disease activity and symptoms including pain, disease flare, inactive disease, and remission. Assessments will collect data on arthritis activity, skin symptoms, and immune system markers during the study. During the study, participants will be monitored regularly through clinical evaluations and questionnaires to assess their arthritis symptoms, disease activity, and overall health. Researchers will measure outcomes from the start of the study through week 264, focusing on safety and how well the disease is controlled. The study is designed to ensure participants health is closely observed while collecting important information on long-term treatment effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - Up to 264 weeks

Participants receive baricitinib orally to evaluate its long-term safety and efficacy for juvenile idiopathic arthritis.

Regular visits throughout treatment period

Trial Site Locations

Total: 80 locations

1

Instituto CAICI SRL

Rosario, Argentina, S2000

Actively Recruiting

2

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Argentina, T4000AXL

Actively Recruiting

3

UZ Gent

Ghent, Belgium, 9000

Actively Recruiting

4

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

5

Faculdade de Medicina da UNESP

Botucatu, Brazil, 18618-686

Actively Recruiting

6

Universidade Federal de Sao Paulo

São Paulo, Brazil, 04024-002

Actively Recruiting

7

Instituto da Crianca do Hospital das Clinicas da FMUSP

São Paulo, Brazil, 05403-000

Actively Recruiting

8

Childrens Hospital of Nanjing Medical University

Nanjing, China, 210008

Actively Recruiting

9

Children's Hospital of Soochow University

Suzhou, China, 215025

Actively Recruiting

10

Detska nemocnice FN Brno

Brno, Czechia, 613 00

Actively Recruiting

11

Vseobecna fakultni nemocnice v Praze

Prague, Czechia, 12808

Actively Recruiting

12

Fakultni nemocnice Motol

Prague, Czechia, 150 06

Actively Recruiting

13

Aarhus Universitetshospital, Skejby

Aarhus, Denmark, 8200

Actively Recruiting

14

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, France, 69500

Actively Recruiting

15

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

16

Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France, 30029

Actively Recruiting

17

Hôpital Universitaire Necker Enfants Malades

Paris, France, 75015

Actively Recruiting

18

Centre Hospitalier Universitaire de Poitiers

Poitiers, France, 86021

Actively Recruiting

19

Sir Ganga Ram Hospital

New Delhi, India, 110060

Actively Recruiting

20

Christian Medical College Vellore

Vellore, India, 632004

Actively Recruiting

21

Rambam Health Care Campus

Haifa, Israel, 3109601

Actively Recruiting

22

Meir Medical Center

Kfar Saba, Israel, 4428164

Actively Recruiting

23

Schneider Children's Medical Center

Petah Tikva, Israel, 49202





Actively Recruiting

24

Sheba Medical Center

Ramat Gan, Israel, 5262100

Actively Recruiting

25

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy, 25123

Actively Recruiting

26

IRCCS Istituto Giannina Gaslini

Genova, Italy, 16147

Actively Recruiting

27

University of Naples Federico II

Naples, Italy, 80131

Actively Recruiting

28

Ospedale Infantile Burlo Garofolo

Trieste, Italy, 34137

Actively Recruiting

29

Institute of Science Tokyo Hospital

Bunkyō, Japan, 113-8519

Actively Recruiting

30

Chiba Children's Hospital

Chiba, Japan, 266-0007

Actively Recruiting

31

Kagoshima University Hospital

Kagoshima, Japan, 890-8520

Actively Recruiting

32

Kanazawa University Hospital

Kanazawa, Japan, 920-8641

Actively Recruiting

33

Niigata University Medical & Dental Hospital

Niigata, Japan, 951-8520

Actively Recruiting

34

Saitama Children's Medical Center

Saitama-shi, Japan, 330 8777

Actively Recruiting

35

Miyagi Children's Hospital

Sendai, Japan, 989-3126

Actively Recruiting

36

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

Actively Recruiting

37

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Japan, 569-8686

Actively Recruiting

38

Kanagawa Children's Medical Center

Yokohama, Japan, 232-8555

Actively Recruiting

39

Yokohama City University Hospital

Yokohama, Japan, 236-0004

Actively Recruiting

40

Investigacion y Biomedicina de Chihuahua

Chihuahua City, Mexico, 31000

Actively Recruiting

41

Instituto de Investigaciones Clínicas para la Salud

Durango, Mexico, 34000

Actively Recruiting

42

Crea de Guadalajara

Guadalajara, Mexico, 44600

Actively Recruiting

43

Clinstile, S.A. de C.V.

México, Mexico, 6700

Actively Recruiting

44

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Mexico, 66460

Actively Recruiting

45

Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

Krakow, Poland, 31-503

Actively Recruiting

46

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, Poland, 91-738

Actively Recruiting

47

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, Poland, 02-637

Actively Recruiting

48

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain, 8950

Actively Recruiting

49

Hospital Infantil Universitario Niño Jesús

Madrid, Spain, 28009

Actively Recruiting

50

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Actively Recruiting

51

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

52

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Actively Recruiting

53

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Turkey (Türkiye), 34098

Actively Recruiting

54

9 Eylul University Hospital

Izmir, Turkey (Türkiye), 35340

Actively Recruiting

55

Bristol Royal Hospital for Children

Bristol, United Kingdom, BS2 8BJ

Actively Recruiting

56

Alder Hey Children's Hospital

Liverpool, United Kingdom, L14 5AB

Actively Recruiting

57

Great Ormond Street Hospital For Children NHS Foundation Trust

London, United Kingdom, WC1N 3JH

Actively Recruiting

58

Oxford University Hospitals - Nuffield Orthopaedic Centre

Oxford, United Kingdom, OX3 7LD

Actively Recruiting

59

Sheffield Children's Hospital

Sheffield, United Kingdom, S10 2TH

Actively Recruiting

60

The Children's Hospital at Westmead

Westmead, Australia, 2145

Active, Not Recruiting

61

Beijing Children's hospital, Capital Medical University

Beijing, China, 100045

Active, Not Recruiting

62

The Children's Hospital of Chongqing Medical University

Chongqing, China, 400065

Active, Not Recruiting

63

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

Active, Not Recruiting

64

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, Germany, 22081

Active, Not Recruiting

65

Asklepios Klinik Sankt Augustin

Sankt Augustin, Germany, 53757

Active, Not Recruiting

66

Universitaetsklinikum Tuebingen

Tübingen, Germany, 72076

Active, Not Recruiting

67

Royal Children's Hospital

Melbourne, Australia, 3052

Not Yet Recruiting

68

Perth Children's Hospital

Perth, Australia, 6009

Not Yet Recruiting

69

Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

Milan, Italy, 20122

Not Yet Recruiting

70

Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

Palermo, Italy, 90127

Not Yet Recruiting

71

Hospital Universitario Virgen Del Rocio

Seville, Spain, 41013

Not Yet Recruiting

72

Landeskrankenhaus Bregenz

Bregenz, Austria, 6900

Completed

73

Cliniques universitaires Saint-Luc

Brussels, Belgium, 1200

Completed

74

Charité Campus Virchow-Klinikum

Berlin, Germany, 13353

Completed

75

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69115

Completed

76





Sri Ramachandra MedicaL College & Research Institute

Chennai, India, 600116

Completed

77

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Chieti, Italy, 66100

Completed

78

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

Completed

79

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

Moscow, Russia, 115522

Completed

80

Scientific Center of Children's Health

Moscow, Russia, 119991

Completed

+−

Leaflet

Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-(phone hidden)) or

P

Physicians interested in becoming principal investigators please contact

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Conception of a Diagnosis, Prognosis and Therapeutic Decisio...

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On this page

AI-Summary

Brief Title

Who Can Participate

AI-Screening

Your Study Journey

Trial Site Locations

Research Team

How is the study designed?

Similar Trials

Frequently Asked Questions

Sponsors

E

Eli Lilly and Company

Lead Sponsor

📌 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 (Rosario)
🏢 DecenTrialz
📍 Rosario