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

Recruiting now

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT06804057

Run by

CorEvitas

People needed

1000

Starts

2024-09-26

Expected to finish

2099-12-31

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• CorEvitas — Waltham, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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