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An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) - -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003341-18-CZ

Enrollment

Registered

2011-09-05

Start date

2011-10-14

Completion date

Unknown

Last updated

2014-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 14.1 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Givinostat Product Code: ITF2357 Pharmaceutical Form: Oral suspension INN or Proposed INN: Givinostat (hydrochloride-monohydrate) CAS Number: 732302-99-7 Current Sponsor code: ITF2357 Ot

monohydrate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be eligible for inclusion into the study, patients have to fulfil the following 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 protocol Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: See Inclusion Criteria section

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this extension study is 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 al least pediACR30 response);Secondary Objective: -;Primary end point(s): Long-term Safety (Incidence of SAEs and AEs of interest);Timepoint(s) of evaluation of this end point: Every 12 weeks of the treatment	—

Measure

Time frame

Main Objective: The purpose of this extension study is 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 al least pediACR30 response);Secondary Objective: -;Primary end point(s): Long-term Safety (Incidence of SAEs and AEs of interest);Timepoint(s) of evaluation of this end point: Every 12 weeks of the treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: -to maintain PedACR30 response at the quarterly controls -to improve the quality of the response (PedACR50, PedACR70) at the quarterly controls ;Timepoint(s) of evaluation of this end point: Every 12 weeks of the treatment	—

Countries

Czech Republic

Contacts

Public ContactPaolo Bettica

Italfarmaco S.p.A.

p.bettica@italfarmaco.com+390264432584

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

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