A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
- Registration Number
- NCT03773965
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
- Participants must have completed a previous study of baricitinib for the treatment of JIA.
- Participants must not have had a permanent discontinuation of baricitinib in the prior study.
- Participants must have not developed an allergy to baricitinib.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Baricitinib Baricitinib Baricitinib given orally.
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Event(s) (SAEs) Baseline through Week 264 Number of participants with one or more SAEs
Number of Participants with Permanent Investigational Product Discontinuations Baseline through Week 264 Number of participants with permanent investigational product discontinuations
- Secondary Outcome Measures
Name Time Method Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Baseline, Week 264 Change from baseline in SPARCC enthesitis index
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) Baseline, Week 264 Change from baseline in JSpADA
Change from Baseline in Immunoglobulin Levels Baseline, Week 264 Change from baseline in immunoglobulin levels
Change from Baseline in Immunophenotyping (T Cells) Baseline, Week 264 Change from baseline in immunophenotyping (T Cells)
Change of Immunoglobulin G (IgG) Titers Pre-Vaccination to 12 Weeks Post-Vaccination Change of IgG titers
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
Change from Baseline in Psoriasis Area and Severity Index (PASI) Baseline, Week 264 Change from baseline in PASI
Proportion of Participants with Inactive Disease Week 264 Proportion of participants with inactive disease
Proportion of Participants with Minimal Disease Activity Week 264 Proportion of participants with minimal disease activity
Proportion of Participants in Remission Week 264 Proportion of participants in remission
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) Baseline, Week 264 Change from baseline of originating study in JADAS27
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) Week 264 Proportion of participants achieving PedACR30
Proportion of Participants who have Disease Flare Baseline through Week 264 Proportion of participants who have disease flare
Trial Locations
- Locations (88)
Instituto CAICI SRL
🇦🇷Rosario, Santa Fe, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital
🇦🇺Melbourne, Victoria, Australia
Perth Children's Hospital
🇦🇺Perth, Western Australia, Australia
Landeskrankenhaus Bregenz
🇦🇹Bregenz, Vorarlberg, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
🇦🇹Vienna, Wien, Austria
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Bruxelles-Capitale, Région De, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, 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, Brazil
Children's Hospital Capital Institute of Pediatrics
🇨🇳Beijing, Beijing, China
Beijing Children's hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Children's Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Childrens Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Children's Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Detska nemocnice FN Brno
🇨🇿Brno, Brno-město, Czechia
Fakultni nemocnice Motol
🇨🇿Praha, Praha 5, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes, Gard, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, Paris, France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
🇫🇷Bron, Rhône-Alpes, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, Vienne, France
Hôpital Universitaire Necker Enfants Malades
🇫🇷Paris, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Baden-Württemberg, Germany
Asklepios Klinik Sankt Augustin
🇩🇪Sankt Augustin, Nordrhein-Westfalen, Germany
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
🇩🇪Hamburg, Germany
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Sri Ramachandra MedicaL College & Research Institute
🇮🇳Chennai, Tamil Nadu, India
Christian Medical College Vellore
🇮🇳Vellore, Tamil Nadu, India
Meir Medical Center
🇮🇱Kfar Saba, HaMerkaz, Israel
Schneider Children's Medical Center
🇮🇱Petah Tikva, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Rambam Health Care Campus
🇮🇱Haifa, Ḥeifā, Israel
University of Naples Federico II
🇮🇹Napoli, Campania, 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
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
🇮🇹Palermo, Sicilia, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
🇮🇹Chieti, Italy
Ospedale Infantile Burlo Garofolo
🇮🇹Trieste, Italy
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Kanagawa Children's Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Miyagi Children's Hospital
🇯🇵Sendai, Miyagi, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Osaka, Japan
Saitama Children's Medical Center
🇯🇵Saitama-shi, Saitama, Japan
Institute of Science Tokyo Hospital
🇯🇵Bunkyō, Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Chiba Children's Hospital
🇯🇵Chiba, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Clinstile, S.A. de C.V.
🇲🇽Mexico, Distrito Federal, Mexico
Crea de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Investigacion y Biomedicina de Chihuahua
🇲🇽Chihuahua, Mexico
Instituto de Investigaciones Clínicas para la Salud
🇲🇽Durango, Mexico
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
🇵🇱Warsaw, Mazowieckie, Poland
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
🇵🇱Krakow, Małopolskie, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
🇵🇱Łódź, Łódzkie, Poland
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, Russian Federation
First Moscow State Medical University n.a. Sechenov
🇷🇺Moscow, Russian Federation
Hospital Sant Joan de Déu
🇪🇸Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital Infantil Universitario Niño Jesús
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
🇹🇷Istanbul, Turkey
9 Eylul University Hospital
🇹🇷Izmir, Turkey
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
Oxford University Hospitals - Nuffield Orthopaedic Centre
🇬🇧Oxford, Oxfordshire, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom