AP
- Conditions
- Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)MedDRA version: 14.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-003341-18-CZ
- Lead Sponsor
- Italfarmaco S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Efficacy:<br>-to maintain PedACR30 response at the quarterly controls <br>-to improve the quality of the response (PedACR50, PedACR70) at the quarterly controls<br>;Timepoint(s) of evaluation of this end point: Every 12 weeks of the treatment