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

NCT06804057 | Recruiting FDA Drug

• 1 other identifier: CorEvitas-SLE-800
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; SLE; Lupus

Outcome Measures

Primary Outcomes (2)

• SLE epidemiology and presentation,

  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

  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

Interventions

Blood Collection OTHER

Blood will be collected for the subjects who are willing to participate in the optional biorepository

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• To be eligible to participate in this registry, an individual must meet all the following criteria:
• Has been diagnosed with SLE by a rheumatologist or a qualified rheumatology practitioner.
• 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.
• Willing and able to provide informed consent.
• 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.
• 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

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in the registry:
• Is participating in a double-blind clinical trial for a SLE drug
• 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

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

CorEvitas

Waltham, Massachusetts, 02451, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood for serum, plasma, DNA, and RNA

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

CorEvitas, LLC

CONTACT

(508) 408-5435; corevitasregistrytrials@corevitas.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: January 31, 2025
• Study Start: September 26, 2024
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

US (1)