Status:
TERMINATED
Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis
Lead Sponsor:
Italfarmaco
Conditions:
Polyarticular Course Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
The present study has been designed in order to evaluate the efficacy and safety of two doses of Givinostat in subjects with polyarticular course JIA Givinostat ready-to-use suspension especially int...
Detailed Description
Non-clinical data on Givinostat, support a potent anti-inflammatory mechanism of action which can potentially slow the arthritic destructive process. This rationale seems to be confirmed by the prelim...
Eligibility Criteria
Inclusion
- patients of both genders, aged 2 to 17 years, with established diagnosis of polyarticular course Juvenile Idiopathic Arthritis (see before for specific subtypes) according to ILAR (International League Against Rheumatism) criteria (Petty RE et al., 2004) for at least six months before the study entry
- age at polyarticular JIA diagnosis \< 16 years
- active disease for at least 6 months prior to enrolment as defined by the following criteria:
- presence of at least 5 active joints (those with swelling or, in the absence of swelling, limited range of motion accompanied by pain/tenderness)
- inadequate response to, or intolerance to, at least one biologic agent such as, but not limited to, etanercept, infliximab, and adalimumab.
- maximum allowed steroid dose 0.2 mg/kg/day or 10 mg/day (whichever is lower) of prednisone or equivalent
- in case of concomitant methotrexate treatment, it has to be on a stable dose ≤15 mg/m2 weekly for at least 1 month before patient's enrolment
- other disease-modifying anti-rheumatic drugs possibly previously introduced have to be discontinued for a period of at least five half-lives
- concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient's enrolment
Exclusion
- patient with fever related to JIA or other systemic features of JIA during 12 months before entering the study
- active bacterial or mycotic infection requiring antimicrobial treatment
- episode of macrophage activation syndrome in the last 6 months
- 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) (Appendix C)
- clinically significant cardiovascular disease
- 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
- psychiatric illness/social situations that would limit compliance with study medication and protocol requirements
- inherited metabolic diseases
- presence of malignancy
- pregnancy or lactation
- positive blood test for HIV
- active EBV infection, active B and/or C hepatitis
- platelet count \<100x109/L
- absolute neutrophil count \<1.5x109/L
- serum creatinine \>2xULN (Upper limit of normal).
- total serum bilirubin \>1.5xULN.
- serum AST/ALT \> 3xULN.
- congenital heart and/or central nervous system disorders
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01261624
Start Date
October 1 2010
End Date
March 1 2013
Last Update
April 16 2014
Active Locations (13)
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1
Universitair Ziekenhuis Gent
Ghent, Gent, Belgium, 9000
2
1st Faculty of Medicine and General Faculty Hospital
Prague, Prague, Czechia, 12109
3
Ospedale Meyer
Florence, FI, Italy, 50139
4
Policlinico G. Martino
Messina, ME, Italy, 98125