CorEvitas SLE medication safety and effectiveness registry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CorEvitas
  Waltham, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: CorEvitas, LLC
• Email: corevitasregistrytrials@corevitas.com
• Phone: (508) 408-5435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.