JAHW; Baricitinib in 2-18 year olds with JIA-U or chronic ANA+ Uveitis
Research type
Research Study
Full title
An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis
IRAS ID
262204
Contact name
Athimalaipet Ramanan
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2019-000119-10
Duration of Study in the UK
6 years, 9 months, 8 days
Research summary
Juvenile idiopathic arthritis (JIA) is an autoimmune, chronic inflammatory disease of the joints and is the most common type of arthritis diagnosed in children aged under 16. JIA accounts for approximately 75% of all cases of paediatric anterior uveitis, and is the most common systemic disorder associated with uveitis in childhood. An anti-nuclear antibody (ANA) test looks for antibodies that react against nuclei in human tissue. Uveitis is reported to occur in about 30% of patients with JIA who are ANA positive, regardless of the type of arthritis present. If left untreated, uveitis may result in cataracts, glaucoma and even blindness.
The study medication, baricitinib, works by inhibiting JAK/STAT signalling and has been shown to reduce inflammation, pain and improve quality of life. Baricitinib has demonstrated clinical efficacy and safety for different autoimmune diseases such as rheumatoid arthritis, psoriasis, atopic dermatitis and lupus.
This study is an open-label, active-controlled, randomised study evaluating the safety and efficacy of oral baricitinib for patients aged 2 to 18 years with JIA-uveitis or chronic ANA-positive uveitis who have had an insufficient response or intolerance to treatment with at least methotrexate and steroid eye drops. The study involves three periods; screening, open-label treatment and post-treatment follow-up. The treatment period is split into two parts:
• Part A – patients will receive either baricitinib (orally, once daily) or adalimumab (subcutaneously, every other week) for 24 weeks;
• Part B – Patients will continue to receive the same treatment as in Part A. At week 48, patients receiving adalimumab will switch to baricitinib and continue on this treatment until the end of the study.
Study assessments include: physical and eye examinations, questionnaires, blood and urine tests and a chest x-ray, if applicable. The post-treatment follow-up period will occur 28 days after the last dose of investigational product.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0442
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion