Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:18 AM
Study NCT ID:
NCT05637112
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2022-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
ASTER: Anifrolumab Study for Treatment Effectiveness in the Real World Multi-National, Observational, Post-Launch Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
ASTER
Brief Summary:
Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.
Detailed Description:
ASTER is a multi-country, single-arm, prospective, observational study. The study will be initiated on a country-by country basis following the commercial launch of anifrolumab. ASTER is a cohort study, with 1-year retrospective baseline data and 5 years of follow-up data.
The minimum enrolment period is anticipated to be 18 months (± 5 months) per country, but it may be extended, if necessary, to reach the overall study target.
In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Data collection will continue for all patients including those who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study. Relevant clinical data collection will continue for the entire follow up while patient reported outcome (PRO) data collection will continue only up to the 3-year follow up.
The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations.
The eCRFs will be accessed through secure web-based portals and will be used to ensure consistent data collection for each healthcare provider involved in this study.
Electronic data collection will be the only method of data collection in this study.
The minimum enrolment period is anticipated to be 18 months (± 5 months) per country, but it may be extended, if necessary, to reach the overall study target.
In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Data collection will continue for all patients including those who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study. Relevant clinical data collection will continue for the entire follow up while patient reported outcome (PRO) data collection will continue only up to the 3-year follow up.
The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations.
The eCRFs will be accessed through secure web-based portals and will be used to ensure consistent data collection for each healthcare provider involved in this study.
Electronic data collection will be the only method of data collection in this study.
Study Oversight
Has Oversight DMC:
False
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?: