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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03773978
Collaborator
(none)
220
Enrollment
86
Locations
3
Arms
37.3
Actual Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)
Actual Study Start Date :
Dec 17, 2018
Actual Primary Completion Date :
Jan 26, 2022
Actual Study Completion Date :
Jan 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Baricitinib Open-Label

Baricitinib given orally.

Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104

    		•
    Experimental: Baricitinib Double Blind

    Baricitinib given orally.

    Drug: Baricitinib
    Administered orally.
    Other Names:
  • LY3009104

    		•
    Placebo Comparator: Placebo Double Blind

    Placebo given orally.

    Drug: Placebo
    Administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Time to Disease Flare [Week 12 to Week 44]

      Time to disease flare

    Secondary Outcome Measures

    1. Proportion of Participants Achieving Pediatric American College of Rheumatology 30 responder index (PedACR30) [Week 12 to Week 44]

      Proportion of participants achieving PedACR30

    2. Proportion of Participants with Inactive Disease [Week 12 to Week 44]

      Proportion of participants with inactive disease

    3. Proportion of Participants with Minimal Disease Activity [Week 12 to Week 44]

      Proportion of participants with minimal disease activity

    4. Proportion of Participants in Remission [Week 24 to Week 44]

      Proportion of participants in remission

    5. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [Baseline, Week 44]

      Change from baseline in juvenile arthritis disease activity score

    6. 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 44]

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

    7. Change from Baseline in Psoriasis Area and Severity Index (PASI) Score [Baseline, Week 44]

      Change from baseline in PASI score

    8. Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [Baseline, Week 44]

      Change from baseline in SPARCC enthesitis index

    9. Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) [Baseline, Week 44]

      Change from baseline in JSpADA

    10. Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) [Baseline through Week 44]

      PK: Cmax, ss of Baricitnib

    11. PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [Baseline through Week 44]

      PK: AUC, ss of Baricitnib

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

      Change from baseline in immunophenotyping (T Cells)

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

      Change of immunoglobulin G (IgG) titers

    14. Acceptability Assessment [Week 44]

      Participants were evaluated for baricitinib acceptability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the ease of use of baricitinib: Very difficult (or hard), difficult (or hard), neither easy nor hard, easy, or very easy.

    15. Palatability Assessment [Week 44]

      Participants were evaluated for baricitinib palatability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the taste and smell of baricitinib: Disliked very much, disliked, neither liked nor disliked, liked, or like very much.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto CAICI SRL Rosario Santa Fe Argentina 2000
    2 Centro Medico Privado de Reumatologia 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 Childrens Hospital Melbourne Parkville Victoria Australia 3050
    6 Perth Children's Hospital Nedlands Western Australia Australia 6009
    7 LKH Bregenz Bregenz Vorarlberg Austria 6900
    8 AKH Wien Austria 1090
    9 UCL- Saint Luc Brussels Brussels-Capital Belgium 1200
    10 UZ Gent-Reuma Gent East Flanders Belgium 9000
    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 Faculdade de Ciências Médicas - UNICAMP Campinas Sao Paulo Brazil 13083-887
    15 Universidade Federal de São Paulo - Escola Paulista de Medicina São Paulo Brazil 04038-001
    16 Children's hospital of Nanjing Nanjing Jiangsu China 210008
    17 Children's Hospital of Chongqing Medical University Chongqing Tianjin City China 200041
    18 Capitol Institute of Pediatrics Children'S Hospital Beijing China 100020
    19 Beijing Children's hospital, Capital Medical University Beijing China 100045
    20 Children's Hospital of Soochow University Suzhou China 215025
    21 Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze Prague Czechia 121 08
    22 Fakultni Nemocnice v Motole Praha 5 Czechia 15006
    23 Paediatric rheumatology Unit København Ø Denmark 2100
    24 Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital Århus N Denmark 8200
    25 Hospices Civils de Lyon - Hôpital Femme Mère Enfant Bron France 69500
    26 Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre Le Kremlin Bicetre France 94270
    27 Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau Nîmes France 30029
    28 GH Necker - Enfants Malades Paris Cedex 15 France 75743
    29 CHU la Miletrie Poitiers France 86000
    30 Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg Germany 69120
    31 Universitätsklinikum Tübingen Tübingen Baden-Württemberg Germany 72076
    32 Asklepios Klinik Sankt Augustin Saint Augustin Nordrhein-Westfalen Germany 53757
    33 HELIOS Klinikum Berlin-Buch Berlin Germany 13125
    34 Charité Universitätsmedizin Berlin Campus Buch Berlin Germany 13353
    35 Schön Klinik Hamburg Eilbek Hamburg Germany 22081
    36 Sri Ramachandra MedicaL College & Research Institute Porur Chennai India 600116
    37 Sir Ganga Ram Hospital New Delhi Delhi India 110060
    38 Christian Medical College Vellore Vellore Tamil Nadu India 632 004
    39 Rambam Medical Center Haifa Israel 3109601
    40 Meir Medical Center Kfar Saba Israel 4428164
    41 Schneider Children's Medical Center Petah Tiqva Israel 4920235
    42 Sheba Medical Center Ramat Gan Israel 5265601
    43 ASST Spedali Civili - Università degli Studi Brescia Italy 25123
    44 Ospedale SS. Annunziata Chieti Italy 66100
    45 Azienda Ospedaliero Universitaria Meyer Firenze Italy 50139
    46 Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini Genova Italy 16147
    47 Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano Italy 20122
    48 Azienda Ospedaliera Universitaria Federico II Napoli Italy 80131
    49 Ospedale Infantile Burlo Garofolo Trieste Italy 34137
    50 Kanazawa University Hospital Kanazawa Ishikawa Japan 920 8641
    51 Kanagawa Children's Medical Center Yokohama Kanagawa Japan 232-8555
    52 Yokohama City University Hospital Yokohama Kanagawa Japan 236-0004
    53 Miyagi Children's Hospital Sendai Miyagi Japan 989-3126
    54 Osaka Medical ＆ Pharma Univ Hp Takatsuki Osaka Japan 569-8686
    55 Saitama Children's Medical Center Saitama-shi Saitama Japan 330 8777
    56 Tokyo Medical And Dental University Medical Hospital Bunkyō Tokyo Japan 113-8519
    57 St. Lukes International Hospital Chuo-Ku Tokyo Japan 104 8560
    58 Tokyo Women's Medical University Hospital Shinjuku-ku Tokyo Japan 162-8666
    59 Kagoshima University Hospital Kagoshima Japan 890-8520
    60 Niigata University Medical & Dental Hospital Niigata Japan 951-8520
    61 Clinstile, S.A. de C.V. Cuauhtemoc Federal District Mexico 06700
    62 CREA de Guadalajara, S.C. Guadalajara Jalisco Mexico 44620
    63 Hospital Univ. "Dr. José Eleuterio González" Monterrey Nuevo León Mexico 64460
    64 Investigacion y Biomedicina de Chihuahua Chihuahua Mexico 31000
    65 Instituto de Investigaciones Aplicadas a la Neurociencia A.C Durango Mexico 34000
    66 Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie Krakow Poland 31-503
    67 CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej Lodz Poland 91-738
    68 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji Warszawa Poland 02-637
    69 V.A. Nasonova Research Institute of Rheumatology Moscow Russian Federation 115522
    70 Morozovsky Children's City Clinical Hospital Moscow Russian Federation 119049
    71 First Moscow State Medical University n.a. Sechenov Moscow Russian Federation 119991
    72 Scientific Center of Children's Health Moscow Russian Federation 119991
    73 Saint-Petersburg State Pediatric Medical University Saint Petersburg Russian Federation 194100
    74 Hospital Sant Joan de Deu Barcelona Cataluna Spain 08950
    75 Complexo Hospitalario Universitario A Coruña, CHUAC La Coruña Spain 15006
    76 Hospital Infantil Universitario Niño Jesús Madrid Spain 28009
    77 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    78 Hospital Universitario La Paz Madrid Spain 28046
    79 Hospital Universitario La Fe de Valencia Valencia Spain 46026
    80 Istanbul University Cerrahpasa Medical Faculty Istanbul Turkey 34098
    81 Dokuz Eylul University Hospital Izmir Turkey 35340
    82 University College Hospital - London London Greater London United Kingdom W1T 7HA
    83 Great Ormond Street Hospital For Children NHS Foundation Trust Bloomsbury London United Kingdom WC1N 3JH
    84 Sheffield Children's Hospital Sheffield South Yorkshire United Kingdom S10 2TH
    85 Bristol Royal Hospital for Children Bristol United Kingdom BS2 8BJ
    86 Alder Hey Children's NHS Foundation Trust Liverpool United Kingdom L14 5AB

    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:
    NCT03773978
    Other Study ID Numbers:
    • 16276
    • I4V-MC-JAHV
    • 2017-004518-24
    First Posted:
    Dec 12, 2018
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 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)
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Juvenile

    Study Results

    No Results Posted as of Feb 3, 2022