NCT01557452

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

Terminated NA Results posted Last updated 6 April 2021

What this trial tests

NA trial testing Givinostat in Juvenile Idiopathic Arthritis in 1 participant. Terminated before completion.

Timeline

28 December 2011

Primary endpoint
27 January 2014

27 January 2014

Quick facts

Lead sponsor	Italfarmaco
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	28 December 2011
Primary completion	27 January 2014
Estimated completion	27 January 2014
Sites	1 location across Czechia

Drugs / interventions tested

• Givinostat (GIVINOSTAT) — full drug profile →

Conditions studied

• Juvenile Idiopathic Arthritis — all drugs for Juvenile Idiopathic Arthritis →

Sponsor

Italfarmaco — full company profile →

Who can join

Adults 2 to 18, any sex, with Juvenile Idiopathic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest Primary · Through end of treatment, up to 108 weeks.

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

non serious AE

Group	Value	95% CI
Givinostat	1

serious AE

Group	Value	95% CI
Givinostat	0

Number of Patients Who Maintained PedACR30 Response Secondary · At weeks 48, 60 and 108

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; * paren

week 48

Group	Value	95% CI
Givinostat	1

week 60

Group	Value	95% CI
Givinostat	0

week 108

Group	Value	95% CI
Givinostat	1

Number of Patients Who Reached PedACR70 Response Secondary · At weeks 48, 60 and 108

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; * paren

week 48

Group	Value	95% CI
Givinostat	0

week 60

Group	Value	95% CI
Givinostat	1

week 108

Group	Value	95% CI
Givinostat	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Through end of treatment, up to 108 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Givinostat

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (1 terms — click to expand)

Reaction	System	Givinostat
Influenza	Infections and infestations	—

Data from ClinicalTrials.gov NCT01557452 adverse events section.

Sponsor's own description

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);

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Histone Deacetylases in Diseases: Where Are We?
   Benedetti R, Conte M, Altucci L. · · 2015 · cited 91× · PMID 24382114 · DOI 10.1089/ars.2013.5776
2. Lysine deacetylase inhibition prevents diabetes by chromatin-independent immunoregulation and β-cell protection.
   Christensen DP, Gysemans C, Lundh M, Dahllöf MS, et al · · 2014 · cited 54× · PMID 24395784 · DOI 10.1073/pnas.1320850111
3. Perspectives on epigenetic-based immune intervention for rheumatic diseases.
   Gray SG. · · 2013 · cited 13× · PMID 23510070 · DOI 10.1186/ar4167