Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314282
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
INTERSTELLAR - Multi-National Observational Prospective Post-Launch Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
INTERSTELLAR
Brief Summary:
INTERSTELLAR study will generate critical prospective 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 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 study will use standardized objectives inclusionexclusion criteria and outcome measures across all countries participating in this study including GCC Qatar KSA Mexico CAMCAR Costa Rica Panama Dominican Republic Colombia Argentina Taiwan and Egypt and any other countries that may be included in the study in order to facilitate a comparison and analysis across all countries included in this study
Detailed Description:
INTERSTELLAR is a multi-country single-arm observational cohort study with 1 year retrospective baseline data and 1 year of prospective follow-up The study will be initiated on a country-by-country basis following the commercial launch of anifrolumab The enrolment period is anticipated to be 12 months per country 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 Relevant clinical and patient reported outcome PRO data collection for the entire follow up will continue for patients who have discontinued anifrolumab during the study unless the patients have withdrawn their consent for participation in the study
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