Juvenile Idiopathic Arthritis Clinical Trial
— JUVE-XOfficial 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)
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.
| Status | Recruiting |
| Enrollment | 190 |
| Est. completion date | December 18, 2030 |
| Est. primary completion date | December 18, 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 18 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital General de Niños Dr. Pedro de Elizalde | Buenos Aires | |
| Argentina | Instituto CAICI SRL | Rosario | Santa Fe |
| Argentina | Centro Medico Privado de Reumatologia | San Miguel de Tucuman | Tucumán |
| Australia | Royal Children's Hospital | Melbourne | Victoria |
| Australia | Perth Children's Hospital | Perth | Western Australia |
| Australia | The Children's Hospital at Westmead | Westmead | New South Wales |
| Austria | Landeskrankenhaus Bregenz | Bregenz | Vorarlberg |
| Austria | Medizinische Universität Wien | Vienna | Wien |
| Belgium | Cliniques universitaires Saint-Luc | Brussels | Bruxelles-Capitale, Région De |
| Belgium | UZ Gent | Gent | Oost-Vlaanderen |
| Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
| Brazil | Faculdade de Medicina da UNESP | Botucatu | São Paulo |
| Brazil | Instituto da Crianca do Hospital das Clinicas da FMUSP | Sao Paulo | São Paulo |
| Brazil | IPITEC | São Paulo | |
| Brazil | Universidade Federal de Sao Paulo | São Paulo | |
| China | Beijing Children's hospital, Capital Medical University | Beijing | Beijing |
| China | Children's Hospital Capital Institute of Pediatrics | Beijing | Beijing |
| China | The Children's Hospital of Chongqing Medical University | Chongqing | Chongqing |
| China | The Second Affiliated Hospital Chongqing Medical University | Chongqing | Chongqing |
| China | Childrens Hospital of Nanjing Medical University | Nanjing | Jiangsu |
| China | Children's Hospital of Soochow University | Suzhou | Jiangsu |
| Czechia | Detska nemocnice FN Brno | Brno | Brno-mesto |
| Czechia | Fakultni nemocnice Olomouc | Olomouc | |
| Czechia | Fakultni nemocnice Motol | Praha | Praha 5 |
| Czechia | Vseobecna fakultni nemocnice v Praze | Praha 2 | |
| Denmark | Aarhus Universitetshospital, Skejby | Aarhus | Midtjylland |
| Denmark | Rigshospitalet | Copenhagen | Hovedstaden |
| France | Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Bron | Rhône-Alpes |
| France | Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | Paris |
| France | Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard |
| France | Hôpital Universitaire Necker Enfants Malades | Paris | |
| France | Centre Hospitalier Universitaire de Poitiers | Poitiers | Vienne |
| Germany | Charité Campus Virchow-Klinikum | Berlin | |
| Germany | Helios Klinikum Berlin-Buch | Berlin | |
| Germany | Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari | Hamburg | |
| Germany | Universitätsklinikum Heidelberg | Heidelberg | Baden-Württemberg |
| Germany | Asklepios Klinik Sankt Augustin | Sankt Augustin | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Tuebingen | Tuebingen | Baden-Württemberg |
| India | Sri Ramachandra MedicaL College & Research Institute | Chennai | Tamil Nadu |
| India | Sir Ganga Ram Hospital | New Delhi | Delhi |
| India | Christian Medical College Vellore | Vellore | Tamil Nadu |
| Israel | Rambam Health Care Campus | Haifa | ?eifa |
| Israel | Meir Medical Center | Kfar Saba | HaMerkaz |
| Israel | Schneider Children's Medical Center | Petah Tikva | HaMerkaz |
| Israel | Sheba Medical Center | Ramat Gan | HaMerkaz |
| Italy | Azienda Ospedaliera Spedali Civili di Brescia | Brescia | |
| Italy | Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti | Chieti | |
| Italy | IRCCS Istituto Giannina Gaslini | Genova | Liguria |
| Italy | Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO | Milano | Lombardia |
| Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milano | Lombardia |
| Italy | University of Naples Federico II | Napoli | Campania |
| Italy | Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli | Palermo | Sicilia |
| Italy | Ospedale Infantile Burlo Garofolo | Trieste | |
| Japan | Tokyo Medical And Dental University Medical Hospital | Bunkyo | Tokyo |
| Japan | Chiba Children's Hospital | Chiba | |
| Japan | Kagoshima University Hospital | Kagoshima | |
| Japan | Kanazawa University Hospital | Kanazawa | Ishikawa |
| Japan | Niigata University Medical & Dental Hospital | Niigata | |
| Japan | Saitama Children's Medical Center | Saitama-shi | Saitama |
| Japan | Miyagi Children's Hospital | Sendai | Miyagi |
| Japan | Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo |
| Japan | Osaka Medical and Pharmaceutical University Hospital | Takatsuki | Osaka |
| Japan | St. Luke's International Hospital | Tokyo | |
| Japan | Kanagawa Children's Medical Center | Yokohama | Kanagawa |
| Japan | Yokohama City University Hospital | Yokohama | Kanagawa |
| Mexico | Investigacion y Biomedicina de Chihuahua | Chihuahua | |
| Mexico | Instituto de Investigaciones Clínicas para la Salud | Durango | |
| Mexico | Crea de Guadalajara | Guadalajara | Jalisco |
| Mexico | Clinstile, S.A. de C.V. | Mexico | Distrito Federal |
| Mexico | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León |
| Poland | Wojewódzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie | Krakow | Malopolskie |
| Poland | Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Lódz | Lódzkie |
| Poland | Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji | Warsaw | Mazowieckie |
| Russian Federation | Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova | Moscow | Moskva |
| Russian Federation | Scientific Center of Children's Health | Moscow | Moskva |
| Spain | Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [Barcelona] |
| Spain | Hospital Infantil Universitario Niño Jesús | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| Spain | Hospital Universitari i Politecnic La Fe | València | |
| Turkey | Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine | Istanbul | |
| Turkey | 9 Eylul University Hospital | Izmir | |
| United Kingdom | Bristol Royal Hospital for Children | Bristol | Bristol, City Of |
| United Kingdom | Alder Hey Children's Hospital | Liverpool | England |
| United Kingdom | Great Ormond Street Hospital For Children NHS Foundation Trust | London | London, City Of |
| United Kingdom | University College Hospital - London | London | Greater London |
| United Kingdom | Oxford University Hospitals - Nuffield Orthopaedic Centre | Oxford | Oxfordshire |
| United Kingdom | Sheffield Children's Hospital | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
Argentina, Australia, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with One or More Serious Adverse Event(s) (SAEs) | Number of participants with one or more SAEs | Baseline through Week 264 | |
| Primary | Number of Participants with Permanent Investigational Product Discontinuations | Number of participants with permanent investigational product discontinuations | Baseline through Week 264 | |
| Secondary | Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) | Proportion of participants achieving PedACR30 | Week 264 | |
| Secondary | Proportion of Participants who have Disease Flare | Proportion of participants who have disease flare | Baseline through Week 264 | |
| Secondary | Proportion of Participants with Inactive Disease | Proportion of participants with inactive disease | Week 264 | |
| Secondary | Proportion of Participants with Minimal Disease Activity | Proportion of participants with minimal disease activity | Week 264 | |
| Secondary | Proportion of Participants in Remission | Proportion of participants in remission | Week 264 | |
| Secondary | Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) | Change from baseline of originating study in JADAS27 | Baseline, Week 264 | |
| Secondary | 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 | |
| Secondary | Change from Baseline in Psoriasis Area and Severity Index (PASI) | Change from baseline in PASI | Baseline, Week 264 | |
| Secondary | Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Change from baseline in SPARCC enthesitis index | Baseline, Week 264 | |
| Secondary | Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) | Change from baseline in JSpADA | Baseline, Week 264 | |
| Secondary | Change from Baseline in Immunoglobulin Levels | Change from baseline in immunoglobulin levels | Baseline, Week 264 | |
| Secondary | Change from Baseline in Immunophenotyping (T Cells) | Change from baseline in immunophenotyping (T Cells) | Baseline, Week 264 | |
| Secondary | Change of Immunoglobulin G (IgG) Titers | Change of IgG titers | Pre-Vaccination to 12 Weeks Post-Vaccination |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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