Clinical trial NCT06804057: CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
Official title: CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
SLE
Lupus
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2025-01-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients enrolled in the registry should be at least 18 years of age

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.

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.

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

Primary outcomes:
measure: SLE epidemiology and presentation,
timeFrame: Every 6 months for 10 years
measure: SLE management, and outcomes
timeFrame: Every 6 months for 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas
state: Massachusetts
Study officials:
References: