NCT06804057

CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: CorEvitas · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
OTHER	Blood Collection	Blood will be collected for the subjects who are willing to participate in the optional biorepository

Timeline

• Start date: 2024-09-26
• Primary completion: 2099-12-31
• Completion: 2099-12-31
• First posted: 2025-01-31
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study