Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
|ClinicalTrials.gov Identifier: NCT00426218|
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : August 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Juvenile Rheumatoid||Drug: ACZ885||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)|
|Study Start Date :||December 2006|
|Primary Completion Date :||March 2010|
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426218
|Novartis Investigative site|
|Principal Investigator:||Novartis||Investigative site|