Last updated 17 days ago
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
58 patients around the world
Available in Mexico, Argentina, Brazil
Eli Lilly and Company
14Research sites
58Patients around the world
This study is for people with
Arthritis
Juvenile idiopathic arthritis
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.To be eligible for cohort 1, patients must be IL-6 inhibitor therapy naïve, have a minimum body weight of 10 kg and be at least 2 years old.To be eligible for cohort 2 (open-label baricitinib), patients must be at least 1 year old.
- 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).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.
Sites
Centro Médico Privado de Reumatología - San Miguel de Tucumán
Recruiting
Hospital General de Niños Pedro de Elizalde
Recruiting
Instituto CAICI - Rosario, Santa Fe
Recruiting
Instituto da Criança e do Adolescente - ICr HCFMUSP
Recruiting
Santa Casa de São Paulo (IPITEC) - Santa Casa Instituto de Pesquisa
Recruiting
Universidad Federal de São Paulo - Unifesp
Recruiting
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
Recruiting
Clinstile S.A de C.V.
Recruiting
Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González
Recruiting
StudyI4V-MC-JAHU
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Juvenile idiopathic arthritis
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04088396
