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

February 5, 2026 updated by: CorEvitas
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients enrolled in the registry should be at least 18 years of age

Description

Inclusion Criteria:

To be eligible to participate in this registry, an individual must meet all the following criteria:

  1. Has been diagnosed with SLE by a rheumatologist or a qualified rheumatology practitioner.
  2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
  3. Willing and able to provide informed consent.
  4. Willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, and home address zip/postal code at a minimum) if required based on registry location and applicable laws and regulations.

  5. In addition, subjects must meet at least one of the following criteria:

    • New diagnosis of SLE (=<12 months) from registry enrollment, OR
    • Initiation of a biologic or immunosuppressant for the treatment of SLE at registry enrollment, OR
    • Lupus Nephritis (LN; class III-V) diagnosed within 2 years of registry enrollment

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the registry:

  1. Is participating in a double-blind clinical trial for a SLE drug
  2. Subjects participating in any non-blinded trial for any indication, with the exception of non-blinded CAR-T or other cell/gene therapies for the treatment of SLE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLE epidemiology and presentation,
Time Frame: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the presentation and natural history.
Every 6 months for 10 years
SLE management, and outcomes
Time Frame: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the management and outcomes.
Every 6 months for 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorEvitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2024

Primary Completion (Estimated)

December 31, 2099

Study Completion (Estimated)

December 31, 2099

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CorEvitas-SLE-800

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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