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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAHU | Other Identifier | Eli Lilly and Company | |
| 2017-004495-60 | EudraCT Number | ||
| 2023-507883-38-00 | EU Trial (CTIS) Number |
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The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Baricitinib | Experimental | Baricitinib given orally. |
|
| Cohort 1 Tocilizumab | Active Comparator | Tocilizumab given Subcutaneously (SC). |
|
| Cohort 2 Baricitinib | Experimental | Baricitinib given orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12 | Percentage of Participants Achieving Adapted PediACR30 Response Criteria | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24 | Percentage of Participants Achieving Adapted PediACR30 Response Criteria | Week 24 |
| Percentage of Participants with Inactive Disease |
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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 | Active, not recruiting | Rosario | S2000 | Argentina | ||
| Centro Medico Privado de Reumatologia |
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| Label | URL |
|---|---|
| A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA | 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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| Tocilizumab | Drug | Administered SC |
|
Percentage of Participants with Inactive Disease
| Week 12 |
| Percentage of Participants with Minimal Disease Activity | Percentage of Participants with Minimal Disease Activity | Week 12 |
| Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 | Change from Baseline in JADAS-27 | Baseline, Week 24 |
| 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 24 |
| Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) | PK: Cmax, ss of Baricitinib | Baseline through Week 24 |
| PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) | PK: AUC, ss of Baricitinib | Baseline through Week 24 |
| Completed |
| SAN M. de Tucuman |
| T4000AXL |
| Argentina |
| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
|
| Faculdade de Medicina da UNESP | Recruiting | Botucatu | 18618-686 | Brazil |
|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | 90035-903 | Brazil |
|
| IPITEC | Not yet recruiting | São Paulo | 01221-020 | Brazil |
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| Universidade Federal de Sao Paulo | Recruiting | São Paulo | 04024-001 | Brazil |
|
| Instituto da Crianca do Hospital das Clinicas da FMUSP | Recruiting | São Paulo | 05403-000 | Brazil |
|
| Detska nemocnice FN Brno | Recruiting | Brno | 613 00 | Czechia |
|
| Vseobecna fakultni nemocnice v Praze | Recruiting | Prague | 12808 | Czechia |
|
| Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Completed | Bron | 69500 | France |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Active, not recruiting | Le Kremlin-Bicêtre | 94270 | France |
| Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau | Completed | Nîmes | 30029 | France |
| Hôpital Universitaire Necker Enfants Malades | Recruiting | Paris | 75015 | France |
|
| Centre Hospitalier Universitaire de Poitiers | Recruiting | Poitiers | 86021 | France |
|
| Sir Ganga Ram Hospital | Recruiting | New Delhi | 110060 | India |
|
| Meir Medical Center | Active, not recruiting | Kfar Saba | 4428164 | Israel |
| Schneider Children's Medical Center | Completed | Petah Tikva | 49202 | Israel |
| Sheba Medical Center | Recruiting | Ramat Gan | 5262100 | Israel |
|
| Azienda Ospedaliera Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
|
| Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti | Completed | Chieti | 66100 | Italy |
| IRCCS Istituto Giannina Gaslini | Completed | Genova | 16147 | Italy |
| Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO | Recruiting | Milan | 20122 | Italy |
|
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Completed | Milan | 20122 | Italy |
| University of Naples Federico II | Completed | Naples | 80131 | Italy |
| Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli | Recruiting | Palermo | 90127 | Italy |
|
| Ospedale Infantile Burlo Garofolo | Recruiting | Trieste | 34137 | Italy |
|
| Institute of Science Tokyo Hospital | Recruiting | Bunkyō | 113-8510 | Japan |
|
| Chiba Children's Hospital | Recruiting | Chiba | 266-0007 | Japan |
|
| Kagoshima University Hospital | Recruiting | Kagoshima | 890-8520 | Japan |
|
| Miyagi Children's Hospital | Recruiting | Sendai | 989-3126 | Japan |
|
| Osaka Medical and Pharmaceutical University Hospital | Completed | Takatsuki | 569-8686 | Japan |
| Kanagawa Children's Medical Center | Active, not recruiting | Yokohama | 232-8555 | Japan |
| Yokohama City University Hospital | Recruiting | Yokohama | 236-0004 | Japan |
|
| Investigacion y Biomedicina de Chihuahua | Completed | Chihuahua City | 31000 | Mexico |
| Instituto de Investigaciones Clínicas para la Salud | Completed | Durango | 34000 | Mexico |
| Crea de Guadalajara | Completed | Guadalajara | 44600 | Mexico |
| Clinstile, S.A. de C.V. | Completed | México | 06700 | Mexico |
| Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León | Active, not recruiting | Monterrey | 66460 | Mexico |
| Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie | Recruiting | Krakow | 31-503 | Poland |
|
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Recruiting | Lodz | 91-738 | Poland |
|
| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji | Recruiting | Warsaw | 02-637 | Poland |
|
| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | 08950 | Spain |
|
| Hospital Infantil Universitario Niño Jesús | Recruiting | Madrid | 28009 | Spain |
|
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
|
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
|
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
|
| Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine | Completed | Istanbul | 34098 | Turkey (Türkiye) |
| 9 Eylul University Hospital | Recruiting | Izmir | 35340 | Turkey (Türkiye) |
|
| Bristol Royal Hospital for Children | Active, not recruiting | Bristol | BS2 8BJ | United Kingdom |
| Alder Hey Children's Hospital | Completed | Liverpool | L12 2AB | United Kingdom |
| Great Ormond Street Hospital For Children NHS Foundation Trust | Completed | London | WC1N 3JH | United Kingdom |
| Oxford University Hospitals - Nuffield Orthopaedic Centre | Active, not recruiting | Oxford | OX3 7HE | United Kingdom |
| Sheffield Children's Hospital | Completed | Sheffield | S10 2TH | United Kingdom |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D005334 | Fever |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| 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 |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
| C502936 | tocilizumab |
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