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

Launched by COREVITAS · Jan 30, 2025

Keywords

ClinConnect Summary

This is a long-term, observational registry for people with Systemic Lupus Erythematosus (SLE), sometimes called lupus. It does not test new drugs. Instead, researchers will collect information from patients and their rheumatology doctors during regular clinic visits to understand how lupus behaves in real life and how current treatments work over time. The study aims to enroll up to about 1,000 adults and follow them for several years, with check-ins roughly every 6 months.

Who can join and what to expect: to participate, you should be 18 or older and have a diagnosis of SLE made by a rheumatologist, and you must be willing to consent and share required information. You might be eligible if you were newly diagnosed within the last year, started a biologic or immunosuppressant for lupus at enrollment, or have lupus nephritis diagnosed within the past two years. Exclusions include people taking part in a blinded drug trial for lupus. Participants may donate a blood sample for optional future research (biorepository). The registry is led by CorEvitas and is FDA-regulated; enrollment is by invitation and results help doctors and patients understand the disease and its treatments in everyday care.

Gender

ALL

Eligibility criteria

• 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