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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03773965
Collaborator
(none)
190
Enrollment
95
Locations
1
Arm
104
Anticipated Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
190 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Apr 5, 2019
Anticipated Primary Completion Date :
Dec 6, 2027
Anticipated Study Completion Date :
Dec 6, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Baricitinib

Baricitinib given orally.

Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) [Baseline through Week 264]

      Number of participants with one or more SAEs

    2. Number of Participants with Permanent Investigational Product Discontinuations [Baseline through Week 264]

      Number of participants with permanent investigational product discontinuations

    Secondary Outcome Measures

    1. Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [Week 264]

      Proportion of participants achieving PedACR30

    2. Proportion of Participants who have Disease Flare [Baseline through Week 264]

      Proportion of participants who have disease flare

    3. Proportion of Participants with Inactive Disease [Week 264]

      Proportion of participants with inactive disease

    4. Proportion of Participants with Minimal Disease Activity [Week 264]

      Proportion of participants with minimal disease activity

    5. Proportion of Participants in Remission [Week 264]

      Proportion of participants in remission

    6. Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) [Baseline, Week 264]

      Change from baseline of originating study in JADAS27

    7. Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item [Baseline, Week 264]

      Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item

    8. Change from Baseline in Psoriasis Area and Severity Index (PASI) [Baseline, Week 264]

      Change from baseline in PASI

    9. Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [Baseline, Week 264]

      Change from baseline in SPARCC enthesitis index

    10. Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) [Baseline, Week 264]

      Change from baseline in JSpADA

    11. Change from Baseline in Immunoglobulin Levels [Baseline, Week 264]

      Change from baseline in immunoglobulin levels

    12. Change from Baseline in Immunophenotyping (T Cells) [Baseline, Week 264]

      Change from baseline in immunophenotyping (T Cells)

    13. Change of Immunoglobulin G (IgG) Titers [Pre-Vaccination to 12 Weeks Post-Vaccination]

      Change of IgG titers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto CAICI SRL Rosario Santa Fe Argentina 2000
    2 Centro de Investigaciones Médicas Tucuman SAN M. DE Tucuman Tucumán Argentina T4000AXL
    3 Hospital General de Niños Dr. Pedro de Elizalde Buenos Aires Argentina C1270AAN
    4 The Sydney Children's Hospitals Network Westmead New South Wales Australia 2145
    5 Royal Children's Hospital Melbourne Victoria Australia 3052
    6 Perth Children's Hospital Perth Western Australia Australia 6009
    7 Landeskrankenhaus Bregenz Bregenz Vorarlberg Austria 6900
    8 AKH Wien Austria 1090
    9 UZ Gent-Reuma Gent East Flanders Belgium 9000
    10 UCL- Saint Luc Bruxelles Belgium 1200
    11 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium 3000
    12 CMIP - Centro Mineiro de Pesquisa Juiz de Fora Minas Gerais Brazil 36010-570
    13 Faculdade de Medicina de Botucatu Botucatu Sao Paulo Brazil 18618-970
    14 Hospital de Clinicas UNICAMP Campinas São Paulo Brazil 13083-887
    15 IPPMG - Biblioteca Asdrubal Costa Rio de Janeiro Brazil 21941-612
    16 IPITEC São Paulo Brazil 01223-001
    17 Núcleo de Gestão e Pesquisa | UNIFESP São Paulo Brazil 04024-002
    18 Beijing Children's hospital, Capital Medical University Beijing Beijing China 100045
    19 Beijing Peking Union Medical College Hospital Beijing Beijing China 100730
    20 The Second Affiliated Hospital Chongqing Medical University Chongqing Chongqing China 400010
    21 The Children's Hospital of Chongqing Medical University Chongqing Chongqing China 400065
    22 Children's hospital of Nanjing Nanjing Jiangsu China 210008
    23 Children's Hospital of Soochow University Suzhou Jiangsu China 210008
    24 Children's Hospital Capital Institute of Pediatrics Beijing China 100020
    25 Detska nemocnice FN Brno Brno Czechia 613 00
    26 Detska revmatologie, Detska klinika, Fakultni nemocnice Olomouc Olomouc Czechia 77900
    27 Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze Prague Czechia 121 08
    28 Fakultni Nemocnice v Motole Praha 5 Czechia 150 06
    29 Aarhus Universitetshospital, Skejby Aarhus Midtjylland Denmark 8200
    30 Paediatric rheumatology Unit København Ø Denmark 2100
    31 Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau Nîmes Gard France 30029
    32 Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre Le Kremlin-Bicêtre Paris France 94270
    33 Hospices Civils de Lyon - Hôpital Femme Mère Enfant Bron France 69500
    34 GH Necker - Enfants Malades Paris Cedex 15 France 75743
    35 CHU la Miletrie Poitiers France 86000
    36 Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg Germany 69120
    37 Universitätsklinikum Tübingen Tübingen Baden-Württemberg Germany 72076
    38 Asklepios Klinik Sankt Augustin Saint Augustin Nordrhein-Westfalen Germany 53757
    39 HELIOS Klinikum Berlin-Buch Berlin Germany 13125
    40 Charité Campus Virchow-Klinikum Berlin Germany 13353
    41 Schön Klinik Hamburg Eilbek Hamburg Germany 22081
    42 Sri Ramachandra MedicaL College & Research Institute Porur Chennai India 600116
    43 Sir Ganga Ram Hospital New Delhi Delhi India 110060
    44 Christian Medical College Vellore Vellore Tamil Nadu India 632 004
    45 Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow Uttar Pradesh India 226014
    46 Rambam Medical Center Haifa Israel 3109601
    47 Meir Medical Center Kfar Saba Israel 4428164
    48 Schneider Children's Medical Center Petah Tiqva Israel 4920235
    49 Sheba Medical Center Ramat Gan Israel 5265601
    50 Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO Milano Lombardia Italy 20122
    51 ASST Spedali Civili - Università degli Studi Brescia Italy 25123
    52 Ospedale SS. Annunziata Chieti Italy 66100
    53 Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini Genova Italy 16147
    54 Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano Italy 20122
    55 Azienda Ospedaliera Universitaria Federico II Napoli Italy 80131
    56 Ospedale Infantile Burlo Garofolo Trieste Italy 34137
    57 Kanazawa University Hospital Kanazawa Ishikawa Japan 920-8641
    58 Kanagawa Children's Medical Center Yokohama Kanagawa Japan 232-8555
    59 Yokohama City University Hospital Yokohama Kanagawa Japan 236-0004
    60 Miyagi Children's Hospital Sendai Miyagi Japan 989-3126
    61 Osaka Medical and Pharmaceutical University Hospital Takatsuki Osaka Japan 569-8686
    62 Saitama Children's Medical Center Saitama-shi Saitama Japan 330 8777
    63 Tokyo Medical and Dental University Hospital Bunkyō Tokyo Japan 113-8519
    64 Tokyo Women's Medical University Hospital Shinjuku-ku Tokyo Japan 162-8666
    65 Chiba Children's Hospital Chiba Japan 266-0007
    66 Kagoshima University Hospital Kagoshima Japan 890-8520
    67 Niigata University Medical & Dental Hospital Niigata Japan 951-8520
    68 St. Luke's International Hospital Tokyo Japan 104-8560
    69 Clinstile, S.A. de C.V. Cuauhtemoc Ciudad De México Mexico 06700
    70 CREA de Guadalajara, S.C. Guadalajara Jalisco Mexico 44620
    71 Hospital Univ. "Dr. José Eleuterio González" Monterrey Nuevo León Mexico 64460
    72 Investigacion y Biomedicina de Chihuahua Chihuahua Mexico 31000
    73 Instituto de Investigaciones Clínicas para la Salud Durango Mexico 34000
    74 Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie Krakow Małopolskie Poland 31-503
    75 CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej Lodz Poland 91-738
    76 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji Warszawa Poland 02-637
    77 Scientific Center of Children's Health Moscow Moskva Russian Federation 119991
    78 Saint-Petersburg State Pediatric Medical University Saint Petersburg Sankt-Peterburg Russian Federation 194100
    79 V.A. Nasonova Research Institute of Rheumatology Moscow Russian Federation 115522
    80 Morozovsky Children's City Clinical Hospital Moscow Russian Federation 119049
    81 Hospital Sant Joan de Deu Barcelona Cataluna Spain 08950
    82 Complexo Hospitalario Universitario A Coruña, CHUAC La Coruña Spain 15006
    83 Hospital Infantil Universitario Niño Jesús Madrid Spain 28009
    84 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    85 Hospital Universitario La Paz Madrid Spain 28046
    86 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013
    87 Hospital Universitario La Fe de Valencia Valencia Spain 46026
    88 Istanbul University Cerrahpasa Medical Faculty-Department of pediatric Rheumatology Istanbul Turkey 34098
    89 Dokuz Eylül Üniversitesi Izmir Turkey 35340
    90 Bristol Royal Hospital for Children Bristol Bristol, City Of United Kingdom BS2 8BJ
    91 Alder Hey Children's Hospital Liverpool England United Kingdom L12 2AB
    92 University College Hospital - London London Greater London United Kingdom W1T 7HA
    93 Great Ormond Street Hospital For Children NHS Foundation Trust Bloomsbury London United Kingdom WC1N 3JH
    94 Oxford University Hospitals - Nuffield Orthopaedic Centre Oxford United Kingdom OX3 7LD
    95 Sheffield Children's Hospital Sheffield United Kingdom S10 2TH

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03773965
    Other Study ID Numbers:
    • 16278
    • I4V-MC-JAHX
    • 2017-004471-31
    First Posted:
    Dec 12, 2018
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Polyarticular JIA
    Oligoarthritis
    Juvenile psoriatic arthritis (JPsA)
    Enthesitis-related juvenile idiopathic arthritis (ERA)
    Systemic JIA with and without systemic features
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Juvenile

    Study Results

    No Results Posted as of Aug 19, 2022