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)

Research summary

Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children. The term idiopathic means “of unknown origin”. There are six subtypes of JIA, systemic JIA is considered an auto inflammatory disease, the other types are considered autoimmune disease. • Systemic JIA • Oligoarticular JIA • Polyarticular JIA • Juvenile psoriatic arthritis • Enthesitis-related JIA • Undifferentiated arthritis The goal of JIA treatment is to reduce inflammation, control pain and improve quality of life. The primary treatments in JIA include nonsteroidal anti-inflammatory drugs (NSAIDs), intra articular and systemic corticosteroids, methotrexate (MTX), and other conventional disease-modifying antirheumatic drug (cDMARDs), then biologic DMARDs. More than one medication can be prescribed to treat JIA. The study medication, baricitinib, works by inhibiting JAK/STAT signalling which has been shown to reduce inflammation, and pain and improve quality of life. Baricitinib has demonstrated clinical efficacy and safety in different autoimmune disease, such as, rheumatoid arthritis, psoriasis, atopic dermatitis and lupus. In this study (JAHX) baricitinib will be evaluated for its effectiveness and safety when taken orally by paediatric patients, over a long term who have completed a previous study. The information from this study will provide an understanding of the benefits gained from versus the risks involved in having baricitinib treatment. The study will involve up to approximately 410 JIA patients aged 1 Year to < 18 Years who have already participated in Studies JAHV or JAHU. Screening for JAHX will occur during the last visit of those studies. The study will provide treatment lasting up to approximately 60 months and a post-treatment follow-up period of 28 days. During the Study patients will undergo joint assessments, have physical exams and blood tests, and answer questionnaires about their condition.

Principal Investigator

Dr Akhila Kavirayani

Contact us

Email: childrensresearch@ouh.nhs.uk

IRAS number

259619