Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
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|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426218
|Novartis Investigative site|
|Principal Investigator:||Novartis||Investigative site|