Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-04 @ 8:43 AM
Study NCT ID:
NCT04750057
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-05-06
First Post:
2021-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anifrolumab Early Access Program
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
An Early Access Program for Anifrolumab Treatment in Adult Patients With Active Systemic Lupus Erythematosus - AMANA
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2021-04
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:
AMANA
Brief Summary:
To provide early access (ie, before marketing authorisation) to anifrolumab 300 mg IV Q4W while receiving standard therapy in adult patients with moderate-to-severe active SLE
Detailed Description:
This is a multi-centre, open-label, early access program (EAP) designed to provide treatment access to intravenous (IV) treatment regimen of 300 mg anifrolumab (MEDI-546) every 4 weeks (Q4W) for eligible patients with moderate-to-severe active SLE while receiving standard therapy. Anifrolumab will be provided free of charge to the patients entering this program.This global EAP will be opened in a sequential fashion, country by country, based on the requesting Treating Physician(s) and local regulations
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: