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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This registry tracks how safe and effective lupus medicines are over time. It is for adults with systemic lupus erythematosus (SLE), often called lupus, who see a rheumatology provider—a specialist in diseases like lupus. Patients and their providers share information during regular care visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have lupus diagnosed by a rheumatologist or another qualified rheumatology provider.
  • Be at least 18 and old enough under local law to consent to the research.
  • Be willing and able to give informed consent, meaning you understand and agree to take part.
  • Be willing and able to share personal details if local rules require it, including your full legal name, sex at birth, birth date, and ZIP or postal code.
  • Meet at least one of these three conditions: lupus diagnosed within the past 12 months; starting a biologic or immune-suppressing medicine for lupus when you join; or class III–V lupus nephritis diagnosed within the past 2 years. These medicines act on the immune system. Lupus nephritis is kidney disease caused by lupus.

Who can't join

  • Be in a double-blind trial of a lupus drug, where neither you nor the study team knows which treatment you get.
  • Be in a non-blinded trial for any condition, where the treatment is known. Non-blinded trials of CAR-T or other cell or gene treatments for lupus are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA