Clinical trial NCT03773978: A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Juvenile Idiopathic Arthritis
Keywords: Polyarticular JIA
Oligoarthritis
Juvenile psoriatic arthritis (JPsA)
Enthesitis-related juvenile idiopathic arthritis (ERA)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-12-12
Enrollment: 220
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.


Eligibility criteria: Inclusion Criteria:

* Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis \[ERA\] including JPsA).
* Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).

Exclusion Criteria:

* Participants must not have systemic JIA, with or without active systemic features.
* Participants must not have persistent oligoarticular arthritis.
* Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.

Primary outcomes:
measure: Time to Disease Flare
timeFrame: Week 12 to Week 44
Secondary outcomes:
measure: Percentage of Participants Achieving PedACR30 Responder Index
timeFrame: Week 16, 20, 24, 28, 32, 36, 40 and 44
measure: Percentage of Participants Achieving PedACR50 Responder Index
timeFrame: Week 16, 20, 24, 28, 32, 36, 40 and 44
measure: Percentage of Participants Achieving PedACR70 Responder Index
timeFrame: Week 16, 20, 24, 28, 32, 36, 40 and 44
measure: Percentage of Participants Achieving PedACR90 Responder Index
timeFrame: Week 16, 20, 24, 28, 32, 36, 40 and 44
measure: Percentage of Participants Achieving PedACR100 Responder Index
timeFrame: Week 16, 20, 24, 28, 32, 36, 40 and 44
measure: Percentage of Participants With Inactive Disease
timeFrame: Week 16, 20, 24, 28, 32, 36, 40 and 44
measure: Percentage of Participants With Minimal Disease Activity
timeFrame: Week 16, 20, 24, 28, 32, 36, 40 and 44
measure: Percentage of Participants in Remission
timeFrame: Week 28, 32, 36, 40 and 44
measure: Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score
timeFrame: Baseline, Week 44
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 44
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline, Week 44
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index
timeFrame: Baseline, Week 44
measure: Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index
timeFrame: Baseline, Week 44
measure: Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
timeFrame: For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)
measure: PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)
timeFrame: For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)
measure: Change From Baseline in Immunoglobulin Levels
timeFrame: Baseline, Week 12
measure: Number of Participants With Change of Immunoglobulin G (IgG) Titers
timeFrame: Pre-Vaccination to 4 and 12 Weeks Post-Vaccination
measure: Number of Participants With Product Acceptability and Palatability Assessment
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Instituto CAICI SRL
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Hospital General de Niños Dr. Pedro de Elizalde
city: Westmead
country: Australia
facility: The Sydney Children's Hospitals Network
state: New South Wales
city: Parkville
country: Australia
facility: Royal Childrens Hospital Melbourne
state: Victoria
city: Nedlands
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Bregenz
country: Austria
facility: LKH Bregenz
state: Vorarlberg
city: Wien
country: Austria
facility: AKH
city: Brussels
country: Belgium
facility: UCL- Saint Luc
state: Brussels-Capital
city: Gent
country: Belgium
facility: UZ Gent-Reuma
state: East Flanders
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Juiz de Fora
country: Brazil
facility: CMIP - Centro Mineiro de Pesquisa
state: Minas Gerais
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu
state: Sao Paulo
city: Campinas
country: Brazil
facility: Faculdade de Ciências Médicas - UNICAMP
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo - Escola Paulista de Medicina
city: Nanjing
country: China
facility: Children's hospital of Nanjing
state: Jiangsu
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Tianjin City
city: Beijing
country: China
facility: Capitol Institute of Pediatrics Children'S Hospital
city: Beijing
country: China
facility: Beijing Children's hospital, Capital Medical University
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
city: Prague
country: Czechia
facility: Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice v Motole
city: København Ø
country: Denmark
facility: Paediatric rheumatology Unit
city: Århus N
country: Denmark
facility: Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
city: Le Kremlin Bicetre
country: France
facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
city: Paris Cedex 15
country: France
facility: GH Necker - Enfants Malades
city: Poitiers
country: France
facility: CHU la Miletrie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Saint 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 Universitätsmedizin Berlin Campus Buch
city: Hamburg
country: Germany
facility: Schön Klinik Hamburg Eilbek
city: Porur
country: India
facility: Sri Ramachandra MedicaL College & Research Institute
state: Chennai
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Vellore
country: India
facility: Christian Medical College Vellore
state: Tamil Nadu
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tiqva
country: Israel
facility: Schneider Children's Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Brescia
country: Italy
facility: ASST Spedali Civili - Università degli Studi
city: Chieti
country: Italy
facility: Ospedale SS. Annunziata
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
city: Genova
country: Italy
facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
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 ＆ Pharma Univ Hp
state: Osaka
city: Saitama-shi
country: Japan
facility: Saitama Children's Medical Center
state: Saitama
city: Bunkyō
country: Japan
facility: Tokyo Medical And Dental University Medical Hospital
state: Tokyo
city: Chuo-Ku
country: Japan
facility: St. Lukes International Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Cuauhtemoc
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Federal District
city: Guadalajara
country: Mexico
facility: CREA de Guadalajara, S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Univ. "Dr. José Eleuterio González"
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C
city: Krakow
country: Poland
facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
city: Lodz
country: Poland
facility: CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
city: Moscow
country: Russian Federation
facility: V.A. Nasonova Research Institute of Rheumatology
city: Moscow
country: Russian Federation
facility: Morozovsky Children's City Clinical Hospital
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. Sechenov
city: Moscow
country: Russian Federation
facility: Scientific Center of Children's Health
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Pediatric Medical University
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
state: Cataluna
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña, CHUAC
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital
city: London
country: United Kingdom
facility: University College Hospital - London
state: Greater London
city: Bloomsbury
country: United Kingdom
facility: Great Ormond Street Hospital For Children NHS Foundation Trust
state: London
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
state: South Yorkshire
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
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: