A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Registration Number
- NCT04088396
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
- Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
- Participants must have at least 2 active joints at screening and baseline
- Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
- Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age
- Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
- Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
- Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
- Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
- Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
- Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
- Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection
- Participants must not have a positive test for hepatitis B virus
- Participants must not have evidence of active tuberculosis (TB) or untreated latent TB
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Baricitinib Baricitinib Baricitinib given orally. Cohort 1 Tocilizumab Tocilizumab Tocilizumab given Subcutaneously (SC). Cohort 2 Baricitinib Baricitinib Baricitinib given orally.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12 Week 12 Percentage of Participants Achieving Adapted PediACR30 Response Criteria
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24 Week 24 Percentage of Participants Achieving Adapted PediACR30 Response Criteria
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 24 Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) Baseline through Week 24 PK: Cmax, ss of Baricitinib
PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) Baseline through Week 24 PK: AUC, ss of Baricitinib
Percentage of Participants with Inactive Disease Week 12 Percentage of Participants with Inactive Disease
Percentage of Participants with Minimal Disease Activity Week 12 Percentage of Participants with Minimal Disease Activity
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 Baseline, Week 24 Change from Baseline in JADAS-27
Trial Locations
- Locations (126)
Instituto CAICI SRL
🇦🇷Rosario, Santa Fe, Argentina
Centro Medico Privado de Reumatologia
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Hospital General de Niños Dr. Pedro de Elizalde
🇦🇷Buenos Aires, Argentina
Medizinische Universität 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
Hospital de Clínicas Da Universidade Estadual de Campinas
🇧🇷Campinas, São Paulo, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
🇧🇷Sao Paulo, São Paulo, Brazil
IPPMG - Biblioteca Asdrubal Costa
🇧🇷Rio de Janeiro, Brazil
IPITEC
🇧🇷São Paulo, Brazil
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
🇫🇷Vandoeuvre lès Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, Vienne, France
Hôpital Universitaire Necker Enfants Malades
🇫🇷Paris, France
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
Sanjay Gandhi Post Graduate Institute of Medical Sciences
🇮🇳Lucknow, Uttar Pradesh, India
Meir Medical Center
🇮🇱Kfar Saba, HaMerkaz, Israel
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
🇮🇹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
Kanagawa Children's Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Osaka, Japan
Institute of Science Tokyo Hospital
🇯🇵Bunkyō, Tokyo, Japan
Chiba Children's Hospital
🇯🇵Chiba, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
🇲🇽Monterrey, Nuevo León, Mexico
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
Great Ormond Street Hospital For Children NHS Foundation Trust
🇬🇧London, Camden, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, England, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
🇬🇧Oxford, Oxfordshire, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
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
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
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
Universidade Federal de Sao Paulo
🇧🇷São Paulo, Brazil
Detska nemocnice FN Brno
🇨🇿Brno, Brno-město, Czechia
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Schneider Children's Medical Center
🇮🇱Petah Tikva, HaMerkaz, Israel
University of Naples Federico II
🇮🇹Napoli, Campania, Italy
IRCCS Istituto Giannina Gaslini
🇮🇹Genova, Liguria, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
Clinstile, S.A. de C.V.
🇲🇽Mexico, Distrito Federal, Mexico
Crea de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
Investigacion y Biomedicina de Chihuahua
🇲🇽Chihuahua, Mexico
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Miyagi Children's Hospital
🇯🇵Sendai, Miyagi, Japan
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Instituto CAICI SRL
🇦🇷Rosario, Santa Fe, Argentina
Centro Medico Privado de Reumatologia
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Medizinische Universität Wien
🇦🇹Vienna, Wien, Austria
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
Detska nemocnice FN Brno
🇨🇿Brno, Brno-město, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes, Gard, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
🇫🇷Vandoeuvre lès Nancy, Meurthe-et-Moselle, 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
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Meir Medical Center
🇮🇱Kfar Saba, HaMerkaz, Israel
Schneider Children's Medical Center
🇮🇱Petah Tikva, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, 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
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
Institute of Science Tokyo Hospital
🇯🇵Bunkyō, Tokyo, Japan
Chiba Children's Hospital
🇯🇵Chiba, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Clinstile, S.A. de C.V.
🇲🇽Mexico, Distrito Federal, Mexico
Crea de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
🇲🇽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
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
Great Ormond Street Hospital For Children NHS Foundation Trust
🇬🇧London, Camden, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, England, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
🇬🇧Oxford, Oxfordshire, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom