systemic onset juvenile idiopathic arthritis Level: PT Classification code 10059177
Conditions
Interventions
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Product Code: ITF2357
P
Sponsors
ITALFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - established diagnosis of Systemic Onset Juvenile Idiopathic Arthritis SOJIA according to ILAR criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents. - active disease for at least one month prior to enrolment - age at enrolment between 2 and 25 years - age at first SOJIA diagnosis 16 years - reviously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient s enrolment - previously introduced methotrexate treatment for at least three months, without satisfactory results on disease activity or with drug intolerability; and concomitant methotrexate, if any, on a stable dose 61619; 10 mg/m2 weekly for at least four weeks before patient s enrolment - concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient s enrolment 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: - any active infection irrespective of its severity - history of macrophage activation syndrome - clinically significant illness - psychiatric illness - congenital heart and/or central nervous system disorders - inherited metabolic diseases - HIV infection or active hepatitis B and/or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Percentage of patients completing 12 weeks of treatment;Main Objective: To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents;Secondary Objective: 1 to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA 2 to investigate the possibility of steroid dose tapering in patients with active SOJIA during ITF2357 treatment 3 to assess the effect of ITF2357 on levels of circulating cytokines 4 to assess pharmacokinetic properties of ITF2357 | — |
Countries
Italy
Outcome results
None listed