Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485674
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Long-Term Organ Damage Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Long-Term Organ Damage Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus LASER An External Comparator Arm Study for the TULIP Trials Using the University of Toronto Lupus Clinic Cohort
Status:
RECRUITING
Status Verified Date:
2024-10
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:
LASER
Brief Summary:
This is an External control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active Systemic lupus erythematosus SLE Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death loss to follow-up trial dis-enrollment or week 208 assessment in LTE study
Detailed Description:
This is an External Control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active Systemic lupus erythematosus SLE Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death loss to follow-up trial dis-enrollment or week 208 assessment in LTE study Patients in the University of Toronto Lupus Clinic will be indexed at the first date of clinical assessment within the patient enrollment period for which they satisfy all eligibility criteria and are receiving at least one eligible SOC treatment ie their index assessment and will be followed up until the earliest occurrence of death loss to follow-up UTLC disenrollment or end of study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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