JAHU; Oral baricitinib in patients 1-18 years with systemic JIA
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less Than 18 Years Old with Systemic Juvenile Idiopathic Arthritis
IRAS ID
264683
Contact name
Athimalaipet Ramanan
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-004495-60
Duration of Study in the UK
3 years, 0 months, 24 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. Systemic JIA (sJIA) is the most severe form of JIA and can cause fever, rash, swelling and pain in the joints. sJIA is distinguished from other JIA subtypes by the presence of fever in addition to arthritis.
The goal of JIA treatment is to reduce inflammation, control pain and improve quality of life. The primary treatments for sJIA include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, biologic DMARDs and methotrexate (MTX).
The study medication, baricitinib, works by inhibiting JAK/STAT signalling which 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.
The current study is a randomised, double-blind, placebo-controlled, withdrawal, safety and efficacy study of oral baricitinib in patients from 1 year to less than 18 years old with sJIA. The aim of the current study is to evaluate the efficacy and safety of oral baricitinib when administered once daily (QD) to paediatric patients with sJIA.
The study consists of three periods:
1. Proof of concept (PoC): 3-week PK/safety/fever/C-reactive protein assessment to evaluate the exposure and safety profiles of baricitinib in paediatric patients;
2. Open-Label Lead-In (OLLI): patients will receive baricitinib QD for a 24-week period;
3. Double-Blind Withdrawal (DBW): patients will be randomized to receive either placebo or remain on the same bariticinib dose for up to 32 weeks or until the occurrence of a disease flare, whichever occurs first.Patients who complete the DBW period or experience a disease flare during the DBW period may enrol into an open-label extension (OLE) study I4V-MC-JAHX.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0443
Date of REC Opinion
19 Aug 2019
REC opinion
Further Information Favourable Opinion