A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1 946; Monoclonal Antibody ACZ885 Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis SJIA - CACZ885A2203

• Conditions: Sistemic Juvenile Idiopathic Arthritis; MedDRA version: 9.1Level: LLTClassification code 10059177Term: Juvenile arthritis

• Registration Number: EUCTR2006-001834-42-IT
• Lead Sponsor: OVARTIS PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

male female subjects aged 4 to 20 having passed screening exams female child bearing potential with negative pregnancy test at screening and willing to use contraception for three months afetr the end of treatment
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

use of etanercept in the four weeks prior to the baseline visit adalimumab in the eight weeks prior to the baseline visit infliximab in the 8 w prior to baseline visit

Study & Design

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