Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048542
Status:
COMPLETED
Last Update Posted:
2011-08-22
First Post:
2002-11-01
Brief Title:
Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis JIA
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study of the Safety Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter Phase 3 randomized placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis JIA who are either methotrexate MTX treated or non-MTX treated
Detailed Description:
The study design for this clinical trial was chosen to evaluate adalimumab in subjects who were either methotrexate MTX-naive or had been withdrawn from MTX at least 2 weeks prior to study drug administration non-MTX stratum or were inadequate responders to MTX and continued MTX treatment MTX stratum The study consisted of 4 phases a 16-week Open-label Lead-in OL LI a 32-week Double-blind DB phase an up to 136-week Open-label Extension Body Surface Area OLE BSA phase and an up to 224-week OLE Fixed Dose FD phase All subjects who met entry criteria were enrolled into one of the appropriate strata and received adalimumab plus concomitant MTX in the MTX stratum in the 16 week OL LI phase of the study All subjects who responded to adalimumab during the OL LI phase were to be enrolled in the DB phase of the study and randomized to receive adalimumab plus concomitant MTX in the MTX stratum or placebo plus concomitant MTX in the MTX stratum Subjects in the DB phase received either adalimumab 24 mgm2 BSA up to a maximum of 40 mg total body dose or placebo subcutaneously SC administered every other week eow Adalimumab or placebo was administered for an additional 32 weeks or until flare of disease based on PedACR30 response criteria a worsening of 30 or more in 3 of the 6 response variables Parents global assessment of subjects overall well-being by visual analog scale VAS Physicians global assessment PhGA of subjects disease severity by VAS number of active joints joints with swelling not due to deformity or joints with limitation of passive motion LOM pain tenderness or both number of joints with LOM Childhood Health Assessment Questionnaire CHAQ and CRP levels a minimum of 2 active joints and no more than 1 indicator improving by 30 or more whichever occurred earlier For subjects who did not have a disease flare the DB phase was completed at Week 48 Subjects who experienced disease flare during the DB phase or subjects who completed 48 weeks of the study were given the option to receive adalimumab for up to a minimum of 44 weeks up to a maximum of 136 weeks in the OLE BSA phase before being eligible to switch to the OLE FD phase In this phase subjects received OL adalimumab 24 mgm2 BSA up to a maximum of 40 mg total body dose SC eow All subjects who completed at least 44 weeks of OLE BSA treatment were given the opportunity to continue into the OLE FD phase for up to 224 weeks of additional adalimumab exposure In this phase subjects weighing less than 30 kg were treated with a fixed dose of 20 mg of adalimumab SC eow Subjects weighing 30 kg or more were treated with a fixed dose of 40 mg of adalimumab SC eow
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None