Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis
Conditions
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
Co
Sponsors
Italfarmaco S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients of both genders, aged 2 to less than 18 years, with established diagnosis of polyarticular course Juvenile Idiopathic Arthritis (see before for specific subtypes) according to ILAR criteria for at least six months before the study entry 2. age at polyarticular JIA diagnosis =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. patient with fever related to JIA or other systemic features of JIA during 12 months before entering the study 2. active bacterial or mycotic infection requiring antimicrobial treatment 3. episode of macrophage activation syndrome in the last 6 months 4. a baseline prolongation of QT/QTc interval, use of concomitant medications that prolong the QT/QTc interval or history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) 5. clinically significant cardiovascular disease 6. clinically significant illness i.e. any condition (including laboratory abnormalities) 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 7. psychiatric illness/social situations that would limit compliance with study medication and protocol requirements 8. inherited metabolic diseases 9. presence of malignancy 10. pregnancy or lactation 11. positive blood test for HIV 12. active EBV infection, active B and/or C hepatitis 13. platelet count 2xULN. 16. total serum bilirubin >1.5xULN. 17. serum AST/ALT > 3xULN. 18. congenital heart and/or central nervous system disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Givinostat administered in two different doses to patients with polyarticular course JIA not adequately responding to the standard treatment, to the purpose of selecting the best dose to be tested on a larger scale in a following phase III clinical trial. ;Secondary Objective: -;Primary end point(s): Proportion of patients achieving an ACR pediatric 30 level of response after 12 weeks (day 85) of treatment. | — |
Countries
Czech Republic, Italy, Slovenia, Spain
Outcome results
None listed