Clinical trial NCT03773965: A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Juvenile Idiopathic Arthritis
Keywords: Polyarticular JIA
Oligoarthritis
Juvenile psoriatic arthritis (JPsA)
Enthesitis-related juvenile idiopathic arthritis (ERA)
Systemic JIA with and without systemic features
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-12-12
Enrollment: 190
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs)
timeFrame: Baseline through Week 264
measure: Number of Participants with Permanent Investigational Product Discontinuations
timeFrame: Baseline through Week 264
Secondary outcomes:
measure: Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
timeFrame: Week 264
measure: Proportion of Participants who have Disease Flare
timeFrame: Baseline through Week 264
measure: Proportion of Participants with Inactive Disease
timeFrame: Week 264
measure: Proportion of Participants with Minimal Disease Activity
timeFrame: Week 264
measure: Proportion of Participants in Remission
timeFrame: Week 264
measure: Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
timeFrame: Baseline, Week 264
measure: Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
timeFrame: Baseline, Week 264
measure: Change from Baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline, Week 264
measure: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
timeFrame: Baseline, Week 264
measure: Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
timeFrame: Baseline, Week 264
measure: Change from Baseline in Immunoglobulin Levels
timeFrame: Baseline, Week 264
measure: Change from Baseline in Immunophenotyping (T Cells)
timeFrame: Baseline, Week 264
measure: Change of Immunoglobulin G (IgG) Titers
timeFrame: Pre-Vaccination to 12 Weeks Post-Vaccination
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Instituto CAICI SRL
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Melbourne
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Perth
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Bregenz
country: Austria
facility: Landeskrankenhaus Bregenz
state: Vorarlberg
city: Vienna
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
state: Wien
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Faculdade de Medicina da UNESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto da Crianca do Hospital das Clinicas da FMUSP
state: São Paulo
city: São Paulo
country: Brazil
facility: IPITEC
city: São Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
city: Beijing
country: China
facility: Children's Hospital Capital Institute of Pediatrics
state: Beijing
city: Beijing
country: China
facility: Beijing Children's hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Children's Hospital of Chongqing Medical University
state: Chongqing
city: Nanjing
country: China
facility: Childrens Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Brno
country: Czechia
facility: Detska nemocnice FN Brno
state: Brno-město
city: Praha
country: Czechia
facility: Fakultni nemocnice Motol
state: Praha 5
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Midtjylland
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Le Kremlin-Bicêtre
country: France
facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
state: Paris
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
state: Rhône-Alpes
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
state: Vienne
city: Paris
country: France
facility: Hôpital Universitaire Necker Enfants Malades
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-Württemberg
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Hamburg
country: Germany
facility: Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Chennai
country: India
facility: Sri Ramachandra MedicaL College & Research Institute
state: Tamil Nadu
city: Vellore
country: India
facility: Christian Medical College Vellore
state: Tamil Nadu
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Ḥeifā
city: Napoli
country: Italy
facility: University of Naples Federico II
state: Campania
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini
state: Liguria
city: Milano
country: Italy
facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Palermo
country: Italy
facility: Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
state: Sicilia
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Chieti
country: Italy
facility: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
city: Trieste
country: Italy
facility: Ospedale Infantile Burlo Garofolo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Children's Medical Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Miyagi Children's Hospital
state: Miyagi
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Saitama-shi
country: Japan
facility: Saitama Children's Medical Center
state: Saitama
city: Bunkyō
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Children's Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Crea de Guadalajara
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Durango
country: Mexico
facility: Instituto de Investigaciones Clínicas para la Salud
city: Warsaw
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
state: Mazowieckie
city: Krakow
country: Poland
facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
state: Małopolskie
city: Łódź
country: Poland
facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
state: Łódzkie
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
state: Moskva
city: Moscow
country: Russian Federation
facility: Scientific Center of Children's Health
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. Sechenov
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
city: Izmir
country: Turkey
facility: 9 Eylul University Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: Bristol, City Of
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: England
city: London
country: United Kingdom
facility: Great Ormond Street Hospital For Children NHS Foundation Trust
state: London, City Of
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals - Nuffield Orthopaedic Centre
state: Oxfordshire
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: