Systemic Lupus ErythematosusNCT06804057
CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
An observational study of Systemic Lupus Erythematosus, run by CorEvitas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Blood Collection
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 31 Dec 2099
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients enrolled in the registry should be at least 18 years of age
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in the registry:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CorEvitas
Waltham, Massachusetts, 02451
Cathy Cheney, 508-408-5435, corevitasregistrytrials@corevitas.com
About this study
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.
Read the detailed description
The objective of the registry is to create a cohort of Systemic lupus erythematosus (SLE) subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for SLE. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of SLE, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Blood Collection
- Keywords
- Systemic Lupus Erythematosus, SLE, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionOther
Blood will be collected for the subjects who are willing to participate in the optional biorepository
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE epidemiology and presentation,
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the presentation and natural history.
Measured: Every 6 months for 10 years
SLE management, and outcomes
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the management and outcomes.
Measured: Every 6 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start26 Sep 2024
- Primary completion31 Dec 2099 (estimated)
- Study completion31 Dec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804057
- Sponsor's protocol ID
- CorEvitas-SLE-800
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
- ClinicalTrials.gov ID
- NCT06804057
- Acronym / sponsor ID
- CorEvitas-SLE-800
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, SLE, Lupus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 31 Dec 2099 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the registry is to create a cohort of Systemic lupus erythematosus (SLE) subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for SLE. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of SLE, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients enrolled in the registry should be at least 18 years of age
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in the registry:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood CollectionBlood will be collected for the subjects who are willing to participate in the optional biorepository | Other | – |
Primary outcome
SLE epidemiology and presentation,
Time frame: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the presentation and natural history.
SLE management, and outcomes
Time frame: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the management and outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CorEvitas, LLC ((508) 408-5435, corevitasregistrytrials@corevitas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE epidemiology and presentation, (time frame: Every 6 months for 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.