CorEvitas SLE medication safety and effectiveness registry

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

This registry collects health and treatment information from adults with lupus to see how commonly used SLE medicines work and how safe they are.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CorEvitas (Research network)
• Drugs / interventions: CAR-T
• Locations: 1 site (Waltham, Massachusetts)
• Trial ID: NCT06804057 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational registry enrolling adults with clinician-diagnosed systemic lupus erythematosus and collecting standardized data over time during routine rheumatology visits. Data come from both patients (including validated patient-reported outcomes) and clinicians (clinician-reported outcomes), and include medication use, comorbidities, adverse events, and periodic blood samples. The registry is designed to describe the natural history of SLE in real-world care and to track long-term safety and effectiveness of commercially available treatments. Collected data may support drug safety surveillance, inform prescribing decisions, and help identify unmet needs in routine clinical practice.

Who should consider this trial

Good fit: Adults (18 or older) diagnosed with SLE by a rheumatologist who can give informed consent and are willing to share health information and, where required, provide identifying details and blood samples, including those newly diagnosed within 12 months or starting a biologic or immunosuppressant at enrollment.

Not a fit: People without a confirmed rheumatologist diagnosis of SLE, those under 18, or those unwilling to share personal health information or participate in routine data and blood collection are unlikely to receive direct benefit from joining.

Why it matters

Potential benefit: If successful, the registry could give patients and doctors clearer, real-world information about the long-term benefits and risks of SLE treatments to inform treatment choices.

How similar studies have performed: Similar observational registries for autoimmune diseases have successfully generated useful real-world safety and effectiveness data, though they complement rather than replace randomized trials.

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

Where this trial is running

Waltham, Massachusetts

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

Study contacts

• Study coordinator: CorEvitas, LLC

Conditions Systemic Lupus Erythematosus; SLE; Lupus