Recruiting

Observational Study

Sponsor:

CorEvitas

Code:

NCT06804057

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Collection

Study Details

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

Study ID

NCT06804057

Start date

Sep 26, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2099

Anticipated

Primary completion date

Dec 31, 2099

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Blood Collection

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

Primary outcome measure

  • SLE epidemiology and presentation, [ Time Frame: Every 6 months for 10 years ]
  • SLE management, and outcomes [ Time Frame: Every 6 months for 10 years ]

Central Contacts and Locations

Locations

CorEvitas

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

More Information

Sponsor

CorEvitas

Last update posted

Feb 6, 2026

Last verified

Jan, 2026

Keywords

  • Systemic Lupus Erythematosus
  • SLE
  • Lupus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CorEvitas on 2026-02-06.