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Recruiting NCT06804057

CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry

Trial Parameters

Condition Systemic Lupus Erythematosus
Sponsor CorEvitas
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-26
Completion 2099-12-31
Interventions
Blood Collection

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;

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