NAP

• Register: EUCTR
• Last refreshed on: 24 March 2014
• Main ID: EUCTR2011-003341-18-CZ
• Date of registration: 05/09/2011
• Prospective Registration: Yes
• Primary sponsor: Italfarmaco S.p.A.
• Public title: NAP
• Scientific title: An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) - -
• Date of first enrolment: 14/10/2011
• Target sample size: 3
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003341-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Czech Republic

Contacts

• Name: Paolo Bettica
• Affiliation: Italfarmaco S.p.A.

• Name: Paolo Bettica
• Affiliation: Italfarmaco S.p.A.

Key inclusion & exclusion 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:
See Inclusion Criteria section


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

Intervention(s)

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
Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl- phenyl carbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride; monohydrate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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

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 Outcome(s)

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

Secondary ID(s)

DSC/11/2357/42

Source(s) of Monetary Support

Italfarmaco S.p.A.