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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAHX | Other Identifier | Eli Lilly and Company | |
| 2017-004471-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Baricitinib given orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) | Number of participants with one or more SAEs | Baseline through Week 264 |
| Number of Participants with Permanent Investigational Product Discontinuations | Number of participants with permanent investigational product discontinuations | Baseline through Week 264 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) | Proportion of participants achieving PedACR30 | Week 264 |
| Proportion of Participants who have Disease Flare |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto CAICI SRL | Recruiting | Rosario | S2000 | Argentina |
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| Label | URL |
|---|---|
| A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Proportion of participants who have disease flare
| Baseline through Week 264 |
| Proportion of Participants with Inactive Disease | Proportion of participants with inactive disease | Week 264 |
| Proportion of Participants with Minimal Disease Activity | Proportion of participants with minimal disease activity | Week 264 |
| Proportion of Participants in Remission | Proportion of participants in remission | Week 264 |
| Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) | Change from baseline of originating study in JADAS27 | Baseline, Week 264 |
| Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item | Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item | Baseline, Week 264 |
| Change from Baseline in Psoriasis Area and Severity Index (PASI) | Change from baseline in PASI | Baseline, Week 264 |
| Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Change from baseline in SPARCC enthesitis index | Baseline, Week 264 |
| Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) | Change from baseline in JSpADA | Baseline, Week 264 |
| Change from Baseline in Immunoglobulin Levels | Change from baseline in immunoglobulin levels | Baseline, Week 264 |
| Change from Baseline in Immunophenotyping (T Cells) | Change from baseline in immunophenotyping (T Cells) | Baseline, Week 264 |
| Change of Immunoglobulin G (IgG) Titers | Change of IgG titers | Pre-Vaccination to 12 Weeks Post-Vaccination |
| Centro de Investigaciones Médicas Tucuman | Recruiting | SAN M. de Tucuman | T4000AXL | Argentina |
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| Royal Children's Hospital | Not yet recruiting | Melbourne | 3052 | Australia |
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| Perth Children's Hospital | Not yet recruiting | Perth | 6009 | Australia |
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| The Children's Hospital at Westmead | Active, not recruiting | Westmead | 2145 | Australia |
| Landeskrankenhaus Bregenz | Completed | Bregenz | 6900 | Austria |
| Cliniques universitaires Saint-Luc | Completed | Brussels | 1200 | Belgium |
| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Faculdade de Medicina da UNESP | Recruiting | Botucatu | 18618-686 | Brazil |
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| Universidade Federal de Sao Paulo | Recruiting | São Paulo | 04024-002 | Brazil |
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| Instituto da Crianca do Hospital das Clinicas da FMUSP | Recruiting | São Paulo | 05403-000 | Brazil |
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| Beijing Children's hospital, Capital Medical University | Active, not recruiting | Beijing | 100045 | China |
| The Children's Hospital of Chongqing Medical University | Active, not recruiting | Chongqing | 400065 | China |
| Childrens Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | 210008 | China |
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| Children's Hospital of Soochow University | Recruiting | Suzhou | 215025 | China |
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| Detska nemocnice FN Brno | Recruiting | Brno | 613 00 | Czechia |
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| Vseobecna fakultni nemocnice v Praze | Recruiting | Prague | 12808 | Czechia |
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| Fakultni nemocnice Motol | Recruiting | Prague | 150 06 | Czechia |
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| Aarhus Universitetshospital, Skejby | Recruiting | Aarhus | 8200 | Denmark |
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| Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Recruiting | Bron | 69500 | France |
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| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau | Recruiting | Nîmes | 30029 | France |
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| Hôpital Universitaire Necker Enfants Malades | Recruiting | Paris | 75015 | France |
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| Centre Hospitalier Universitaire de Poitiers | Recruiting | Poitiers | 86021 | France |
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| Helios Klinikum Berlin-Buch | Active, not recruiting | Berlin | 13125 | Germany |
| Charité Campus Virchow-Klinikum | Completed | Berlin | 13353 | Germany |
| Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari | Active, not recruiting | Hamburg | 22081 | Germany |
| Universitätsklinikum Heidelberg | Completed | Heidelberg | 69115 | Germany |
| Asklepios Klinik Sankt Augustin | Active, not recruiting | Sankt Augustin | 53757 | Germany |
| Universitaetsklinikum Tuebingen | Active, not recruiting | Tübingen | 72076 | Germany |
| Sri Ramachandra MedicaL College & Research Institute | Completed | Chennai | 600116 | India |
| Sir Ganga Ram Hospital | Recruiting | New Delhi | 110060 | India |
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| Christian Medical College Vellore | Recruiting | Vellore | 632004 | India |
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| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
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| Meir Medical Center | Recruiting | Kfar Saba | 4428164 | Israel |
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| Schneider Children's Medical Center | Recruiting | Petah Tikva | 49202 | Israel |
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| Sheba Medical Center | Recruiting | Ramat Gan | 5262100 | Israel |
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| Azienda Ospedaliera Spedali Civili di Brescia | Active, not recruiting | Brescia | 25123 | Italy |
| Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti | Completed | Chieti | 66100 | Italy |
| IRCCS Istituto Giannina Gaslini | Active, not recruiting | Genova | 16147 | Italy |
| Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO | Not yet recruiting | Milan | 20122 | Italy |
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| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Completed | Milan | 20122 | Italy |
| University of Naples Federico II | Active, not recruiting | Naples | 80131 | Italy |
| Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli | Not yet recruiting | Palermo | 90127 | Italy |
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| Ospedale Infantile Burlo Garofolo | Completed | Trieste | 34137 | Italy |
| Institute of Science Tokyo Hospital | Recruiting | Bunkyō | 113-8519 | Japan |
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| Chiba Children's Hospital | Recruiting | Chiba | 266-0007 | Japan |
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| Kagoshima University Hospital | Recruiting | Kagoshima | 890-8520 | Japan |
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| Kanazawa University Hospital | Recruiting | Kanazawa | 920-8641 | Japan |
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| Niigata University Medical & Dental Hospital | Recruiting | Niigata | 951-8520 | Japan |
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| Saitama Children's Medical Center | Recruiting | Saitama-shi | 330 8777 | Japan |
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| Miyagi Children's Hospital | Recruiting | Sendai | 989-3126 | Japan |
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| Tokyo Women's Medical University Hospital | Recruiting | Shinjuku-ku | 162-8666 | Japan |
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| Osaka Medical and Pharmaceutical University Hospital | Recruiting | Takatsuki | 569-8686 | Japan |
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| Kanagawa Children's Medical Center | Recruiting | Yokohama | 232-8555 | Japan |
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| Yokohama City University Hospital | Recruiting | Yokohama | 236-0004 | Japan |
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| Investigacion y Biomedicina de Chihuahua | Recruiting | Chihuahua City | 31000 | Mexico |
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| Instituto de Investigaciones Clínicas para la Salud | Recruiting | Durango | 34000 | Mexico |
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| Crea de Guadalajara | Recruiting | Guadalajara | 44600 | Mexico |
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| Clinstile, S.A. de C.V. | Recruiting | México | 6700 | Mexico |
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| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Recruiting | Monterrey | 66460 | Mexico |
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| Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie | Recruiting | Krakow | 31-503 | Poland |
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| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Recruiting | Lodz | 91-738 | Poland |
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| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji | Recruiting | Warsaw | 02-637 | Poland |
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| Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova | Completed | Moscow | 115522 | Russia |
| Scientific Center of Children's Health | Completed | Moscow | 119991 | Russia |
| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | 8950 | Spain |
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| Hospital Infantil Universitario Niño Jesús | Recruiting | Madrid | 28009 | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| Hospital Universitario Virgen Del Rocio | Not yet recruiting | Seville | 41013 | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine | Recruiting | Istanbul | 34098 | Turkey (Türkiye) |
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| 9 Eylul University Hospital | Recruiting | Izmir | 35340 | Turkey (Türkiye) |
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| Bristol Royal Hospital for Children | Recruiting | Bristol | BS2 8BJ | United Kingdom |
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| Alder Hey Children's Hospital | Recruiting | Liverpool | L14 5AB | United Kingdom |
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| Great Ormond Street Hospital For Children NHS Foundation Trust | Recruiting | London | WC1N 3JH | United Kingdom |
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| Oxford University Hospitals - Nuffield Orthopaedic Centre | Recruiting | Oxford | OX3 7LD | United Kingdom |
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| Sheffield Children's Hospital | Recruiting | Sheffield | S10 2TH | United Kingdom |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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