Long-Term safety and efficacy of baricitinib - I4V-MC-JAHV

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA)

• IRAS ID

  257112

• Contact name

  Athimalaipet Ramanan

• Contact email

  avramanan@hotmail.com

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2017-004518-24

• Duration of Study in the UK

  0 years, 11 months, 6 days

• 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.
  This randomised, double-blind, placebo-controlled, withdrawal, study is sponsored by Lilly and will evaluate the safety and efficacy of baricitinib in patients aged 2 years to less than 18 years old with juvenile idiopathic arthritis. Patients will be included who have an inadequate response or intolerance to cDMARDs. Study JAHV has a safety/PK assessment period (for some patients), an open-label lead-in (OLLI) period, and a double-blind withdrawal (DBW) period. Enrolment will be staggered by age with older patients enrolling before younger patients. Approximately 197 patients are planned to enter the OLLI period to allow 128 patients to be randomised into the DBW period.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  19/NW/0106

• Date of REC Opinion

  23 Apr 2019

• REC opinion

  Further Information Favourable Opinion