CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
Recruiting · NCT06804057 · Observational (researchers observe without assigning treatment) · Lead sponsor: CorEvitas
View the official record on ClinicalTrials.gov →Interventions studied
Blood Collection
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- CorEvitas - Waltham, Massachusetts, United States