Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
Primary Objective of the study:

the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);

Detailed description:
Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA through the inhibition of the production/release of pro-inflammatory cytokines, such as IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.

Arms:
arm 1: Patient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014

Interventions: intervention 1: Givinostat
Intervention descriptions: intervention 1: ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients

Protocol document: