Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339157
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2006-06-16
Brief Title:
Interleukin-1 Receptor Antagonist IL-1RA ANAKINRA IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset ANAJIS
Status:
COMPLETED
Status Verified Date:
2010-07
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:
1 Main objective To test the efficacy of anakinra treatment in children or young adults with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis SO-JIA
2 Design Double blind randomized trial testing the efficacy of one month Anakinra treatment versus placebo 2 groups of 12 patients each All the patients will be treated with anakinra during the following 11 months and the dose of corticosteroids will be gradually tapered descriptive part of the trial to assess the tolerance and efficacy over 12 months
3 Hypothesis 70 significant improvement after 1 month in Anakinra-treated patients versus no more than 10 in the placebo group
4 Main inclusion criteria diagnosis of SO-JIA Durban consensus conference criteria age 2 to 20 years at inclusion active corticosteroid-resistant or -dependent disease no previous IL-1ra treatment
2 Design Double blind randomized trial testing the efficacy of one month Anakinra treatment versus placebo 2 groups of 12 patients each All the patients will be treated with anakinra during the following 11 months and the dose of corticosteroids will be gradually tapered descriptive part of the trial to assess the tolerance and efficacy over 12 months
3 Hypothesis 70 significant improvement after 1 month in Anakinra-treated patients versus no more than 10 in the placebo group
4 Main inclusion criteria diagnosis of SO-JIA Durban consensus conference criteria age 2 to 20 years at inclusion active corticosteroid-resistant or -dependent disease no previous IL-1ra treatment
Detailed Description:
None
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