Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis
Status:
Terminated
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
The present study has been designed in order to evaluate the efficacy and safety of two doses
of Givinostat in subjects with polyarticular course JIA
Givinostat ready-to-use suspension especially intended for paediatric administration, will be
administered orally at different daily doses.
Patients with an established diagnosis of one of the following JIA forms (Polyarticular JIA
rheumatoid factor positive or negative, Oligoarticular extended JIA, Systemic JIA without
active systemic features) will be enrolled.
The treatment regimen will remain unchanged for 12 weeks and the clinical response will by
assessed by applying the ACR Pediatric response criteria. Patients achieving at least an ACR
Pediatric 30 response will continue receiving the assigned dose for 12 further weeks.
After the end of study (week 24) responder patients will be allowed to extend the treatment
until they maintain a clinical benefit.