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

NCT ID: NCT01557452

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-28
• Study Completion Date: 2014-01-27

Brief 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);

Detailed 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.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Givinostat

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

Group Type: EXPERIMENTAL

Givinostat

Intervention Type: DRUG

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

Interventions

Givinostat

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

Intervention Type: DRUG

Other Intervention Names

ITF2357

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Italfarmaco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavla Dolezalova, MD

Role: PRINCIPAL_INVESTIGATOR

General Faculty Hospital Department of Pediatrics and Adolescent Medicine, Praha, Czech Republic

Locations

1st Faculty of Medicine and General Faculty Hospital

Prague, , Czechia

Countries

Czechia

Other Identifiers

2011-003341-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DSC/11/2357/42

Identifier Type: -

Identifier Source: org_study_id