Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078806
Status:
TERMINATED
Last Update Posted:
2019-09-25
First Post:
2004-03-05
Brief Title:
Safety and Efficacy Study of Etanercept Enbrel In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study was terminated because of slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis SOJRA
Detailed Description:
Participants were to receive etanercept at a dose of 04 mgkg twice weekly in Part 1A Participants who had a partial response not able to reduce prednisone dose by 50 of the baseline dose in 5 months while on 04 mgkg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 08 mgkg twice weekly Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders Participants who responded in either Part 1A or Part 1B were randomized into Part 2 where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months In Part 2 participants were stratified by the dosage of etanercept 04 mgkg or 08 mgkg they were receiving in Part 1A or Part 1B Participants could enter Part 3 the open-label re-treatment portion of the study only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2 The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months
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