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

Italfarmaco

Status

Terminated

Conditions

Juvenile Idiopathic Arthritis

Treatments

Drug: Givinostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01557452

DSC/11/2357/42

2011-003341-18 (EudraCT Number)

Details and patient eligibility

About

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);

Full 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.

Enrollment

1 patient

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

subjects who had successfully completed the previous Dose Finding Study and were fully compliant to the inclusion/exclusion criteria described in the previous DSC/08/2357/36

Exclusion criteria

patients with fever related to JIA or other systemic features of JIA during 12 months before entering the study
active bacterial or mycotic infection requiring antimicrobial treatment
episode of macrophage activation syndrome over the last 6 months
baseline prolongation of QT/QTc interval, use of concomitant medications that prolong the QT/QTc interval or history of additional risk factors for TdP.
clinically significant cardiovascular disease
clinically significant illness i.e. any condition that in the opinion of the Investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
inherited metabolic diseases
presence of malignancy
pregnancy or lactation
positive blood test for HIV
active EBV infection, active B and/or C hepatitis
platelet count <100x10(9)/L