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

NCT01557452 | Terminated Results

• 2 other identifiers: DSC/11/2357/422011-003341-18
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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);

Conditions

Juvenile Idiopathic Arthritis

Keywords

JIA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Patients Who Maintained PedACR30 Response

  At weeks 48, 60 and 108

• Number of Patients Who Reached PedACR70 Response

  At weeks 48, 60 and 108

Study Arms (1)

Givinostat

EXPERIMENTAL

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

Drug: Givinostat

Interventions

Givinostat DRUG

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

Also known as: ITF2357

Givinostat

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Italfarmaco: lead
• Parexel: collaborator

Study Sites (1)

1st Faculty of Medicine and General Faculty Hospital

Prague, 12109, Czechia

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

givinostat; givinostat hydrochloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Paolo Bettica, MD
• Organization: Italfarmaco SpA

p.bettica@italfarmaco.com

+39 02 64431

Study Officials

• Pavla Dolezalova, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 19, 2012
• Study Start: December 28, 2011
• Primary Completion: January 27, 2014
• Study Completion: January 27, 2014
• Last Updated: April 6, 2021
• Results First Posted: April 6, 2021

Record last verified: 2021-03

Locations

CZ (1)