Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2022-11-22
Brief Title:
A Study of Anakinra in Japanese Patients With Stills Disease SJIA and AOSD
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Phase 3 Efficacy and Safety Study of Subcutaneous Anakinra in Japanese Patients With Stills Disease SJIA and AOSD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Stills disease Systemic juvenile idiopathic arthritis SJIA and Adult-onset Stills disease AOSD
Detailed Description:
The study consists of a 2-Week randomized double-blind placebo-controlled period followed by a 52-Week open-label phase treatment with anakinra After the last dose of anakinra at Week 54 the safety will be evaluated at a Safety Follow-up visit ie at Week 58
The primary endpoint will be evaluated at Week 2 visit Patients will be randomly assigned to either anakinra or placebo for a period of 2 weeks
The primary endpoint will be evaluated at Week 2 visit Patients will be randomly assigned to either anakinra or placebo for a period of 2 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None