NCT06804057Recruiting
CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 2 Dec 2024
- Start date
- 26 Sept 2024
- Primary completion date
- 31 Dec 2099
- Lead sponsor
- CorEvitas
- Diseases
- Lupus (SLE)
- NCT number
- NCT06804057
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 26 Sept 2024 to the primary completion date, 31 Dec 2099
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- An individual who meets any of the following criteria will be excluded from participation in the registry:
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CorEvitas Coordinator of this site? Confirm its status | Waltham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.