Clinical trial NCT04088396: A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Official title: Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Systemic Juvenile Idiopathic Arthritis
Keywords: Systemic
Fever
Flare
sJIA
JIA
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 58
Sex: ALL
Minimum age (years): 1
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24
timeFrame: Week 24
measure: Percentage of Participants with Inactive Disease
timeFrame: Week 12
measure: Percentage of Participants with Minimal Disease Activity
timeFrame: Week 12
measure: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27
timeFrame: Baseline, Week 24
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 24
measure: Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
timeFrame: Baseline through Week 24
measure: PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)
timeFrame: Baseline through Week 24
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: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
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: Brno
country: Czechia
facility: Detska nemocnice FN Brno
state: Brno-město
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Vandoeuvre lès Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
state: Meurthe-et-Moselle
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: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
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: 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: 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: Bunkyō
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Children's Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University 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. José Eleuterio González, Universidad Autónoma de Nuevo León
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: 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: London
country: United Kingdom
facility: Great Ormond Street Hospital For Children NHS Foundation Trust
state: Camden
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: England
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: