Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis

Sponsor
Italfarmaco
Study ID
NCT01557452
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Givinostat — DRUG
    ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients

Study Details

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);

Key Dates

Start date
Dec 28, 2011
Status verified
Mar 2021
Primary completion
Jan 27, 2014
Completion
Jan 27, 2014

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Givinostat
    Patient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014

Primary Outcome Measure

Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest [ Time Frame: Through end of treatment, up to 108 weeks. ]

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