Clinical Trial: Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Brief Summary: This study is a multi-center, open label, repeated dose, range finding study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and efficacy of ACZ885, a fully human anti-interleukin-1B (anti-IL-1B) monoclonal antibody, given subcutaneously in pediatric subjects with active SJIA.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome:
- Safety, tolerability and immunogenicity of subcutaneous (s.c.) ACZ885
- To assess the initial efficacy profile of s.c. ACZ885: % responder to treatment and time to relapse and control the systemic manifestations of SJIA such as fever.
- pharmacokinetics of ACZ885
- To assess pharmacokinetics (PK) / pharmacodynamics (PD) relationships in order to derive a dose and dosing regimen
Original Primary Outcome: Same as current
Current Secondary Outcome:
- proportion of patients with inactive disease at each dose level.
- To investigate the possibility of corticosteroid tapering.
- biomarker and pharmacogenomic characterization of patients at baseline and to evaluate the treatment response to ACZ885.
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: January 23, 2007
Date Started: December 2006
Date Completion:
Last Updated: August 8, 2011
Last Verified: August 2011
