CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorEvitas
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
The patients enrolled in the registry should be at least 18 years of age
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood Collection
Other interventionBlood will be collected for the subjects who are willing to participate in the optional biorepository
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Every 6 months for 10 years2
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.
Time frame
Every 6 months for 10 years Source ClinicalTrials.gov