At a glance
ClinicalIndex Comparison Record- ✓Established diagnosis of systemic-onset JIA (SOJIA) per ILAR criteria for ≥6 months with inadequate response or intolerance to steroids and/or methotrexate, with or without prior biologic agents
- ✓Active disease for ≥1 month: arthritis plus fever (≥37.5°C daily for ≥5 consecutive days), typical SOJIA rash, serositis (confirmed imaging/ECG), lymphadenopathy (≥1.5 cm or hepato-/splenomegaly on ultrasound), and/or ESR ≥20 mm/h or CRP ≥10 mg/L
- ✓Age 2–25 years at enrolment; age at first SOJIA diagnosis <16 years
- ✓Currently on oral steroids at dose ≥0.2 mg/kg/day prednisolone equivalent, unmodified for ≥4 weeks before enrolment
- ✕Ongoing clinically relevant viral infection (e.g., Herpes zoster, Epstein-Barr, CMV) or history of recurrent serious bacterial infections
- ✕History of macrophage activation syndrome
- ✕Positive serology for anti-HCV, anti-HIV, or HBsAg at screening
- ✕Any previous evidence of coronary disease, cardiac rhythm abnormalities, or congestive heart failure (irrespective of severity)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA)
In Brief
A Phase 2 clinical trial evaluating ITF2357 for Active Systemic and Onset Juvenile Idiopathic Arthritis. Completed, enrolled 17 participants across 5 sites in 2 countries.
Detailed Summary
This study has the following objectives: Primary 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 objectives: * to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA * to investigate the possibility of steroid dose tapering in patients with active SOJIA during ITF2357 treatment * to assess the effect of ITF2357 on levels of circulating cytokines * to assess the pharmacokinetic properties of ITF2357
Study Details
Timeline
Interventions
ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.