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

• Status: Terminated
• Trial end date: 2014-01-27
• Target enrollment: 0
• Participant gender: All

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);

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italfarmaco
• Collaborator: Parexel
• Treatments: Givinostat hydrochloride

Criteria

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