Polyarticular Course Juvenile Idiopathic Arthritis Clinical Trial
Official title:
A Multicenter, Open Label, Dose Finding Study to Evaluate Efficacy and Safety of Givinostat Administered in Two Different Doses in Patients With Poly JIA Not Adequately Responding to the Standard Treatment.
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.
Non-clinical data on Givinostat, support a potent anti-inflammatory mechanism of action
which can potentially slow the arthritic destructive process. This rationale seems to be
confirmed by the preliminary evidences collected in a previous Phase II clinical trial
conducted in children and young adults with systemic JIA.
The present protocol is aimed at collecting new information on safety and efficacy of two
doses of Givinostat for the treatment of JIA.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment