NCT06804057 CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
| NCT ID | NCT06804057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CorEvitas |
| Condition | Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-09-26 |
| Primary Completion | 2099-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-09-26 with a primary completion date of 2099-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06804057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06804057 currently recruiting?
Yes, NCT06804057 is actively recruiting participants. Contact the research team at corevitasregistrytrials@corevitas.com for enrollment information.
Where is the NCT06804057 trial being conducted?
This trial is being conducted at Waltham, United States.
Who is sponsoring the NCT06804057 clinical trial?
NCT06804057 is sponsored by CorEvitas. The trial plans to enroll 1,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.