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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01557452
• Other study ID #: DSC/11/2357/42
• Secondary ID: 2011-003341-18
• Status: Terminated
• Phase: N/A
• Start date: December 28, 2011
• Est. completion date: January 27, 2014

Study information

• Verified date: March 2021
• Source: Italfarmaco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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);

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 27, 2014
• Est. primary completion date: January 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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

Locations

Country	Name	City	State
Czechia	1st Faculty of Medicine and General Faculty Hospital	Praha

Sponsors (2)

Lead Sponsor	Collaborator
Italfarmaco	Parexel

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest	During the entire study period it was reported only one adverse event considered not drug related by the investigator (Mild flu at week 107 of study treatment).; No action was taken and the patient recovered spontaneously	Through end of treatment, up to 108 weeks.
Secondary	Number of Patients Who Maintained PedACR30 Response	This is an open-label treatment extension of the 2010-019094-15 study, an antecedent dose-ranging trial of Givinostat ready-to-use oral suspension formulation. Eligible patients were those who had completed the previous study achieving a clinical benefit, i.e. patients achieving at least an ACR Paediatric 30 (PedACR30).; PedACR30 is defined as at least a 30% improvement from baseline in any three of the following six variables in juvenile idiopathic arthritis (JIA) patients, with no more than one variable worsening by more than 30%: physician's global assessment of disease activity; parent/guardian's or patient's global assessment of overall wellbeing; functional ability; number of joints with active arthritis; number of joints with limited range of motion; ESR.; (ACR stands for American College of Rheumatology)	At weeks 48, 60 and 108
Secondary	Number of Patients Who Reached PedACR70 Response	This is an open-label treatment extension of the 2010-019094-15 study, an antecedent dose-ranging trial of Givinostat ready-to-use oral suspension formulation. Eligible patients were those who had completed the previous study achieving a clinical benefit, i.e. patients achieving at least an ACR Paediatric 30 (PedACR30).; PedACR70 is defined as at least a 70% improvement from baseline in any three of the following six variables in juvenile idiopathic arthritis (JIA) patients, with no more than one variable worsening by more than 30%: physician's global assessment of disease activity; parent/guardian's or patient's global assessment of overall wellbeing; functional ability; number of joints with active arthritis; number of joints with limited range of motion; ESR.; (ACR stands for American College of Rheumatology)	At weeks 48, 60 and 108