Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT06804057
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
Sponsor:
CorEvitas
Organization:
Study Overview
Official Title:
CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
Status:
RECRUITING
Status Verified Date:
2025-01
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:
Prospective, observational registry for subjects with SLE under the care of a rheumatology provider. Longitudinal data are collected from both subjects and their treating rheumatology provider during routine clinical encounters using a structured and standardized data collection method.
Detailed Description:
The objective of the registry is to create a cohort of Systemic lupus erythematosus (SLE) subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for SLE. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of SLE, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: