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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001834-42-IT
• Date of registration: 09/01/2007
• Prospective Registration: No
• Primary sponsor: NOVARTIS PHARMA AG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 13/10/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001834-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

France, Italy, United Kingdom

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Sistemic Juvenile Idiopathic Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10059177 Term: Juvenile arthritis

Intervention(s)

Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Secondary Objective: to evaluate the proportion of patients with inactive disease at each dose level

Main Objective: to evaluate safety, tolerability and immunogenicity of subcutaneous administration of ACZ885 in paediatric subjects with SJIA to evaluate the initial efficacy profile according to ACR to assess PK to assess the relationship between PK and PD to derive a dosage regimen for phase III studies

Primary end point(s): global assessment of disease activity by the PI according to a graduated scale gglobal assessment of subject well being

Secondary ID(s)

CACZ885A2203

2006-001834-42-FR