Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND

• Conditions: systemic onset juvenile idiopathic arthritis; Level: PTClassification code 10059177

• Registration Number: EUCTR2006-000089-35-IT
• Lead Sponsor: ITALFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified