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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Blood Collection
  Blood will be collected for the subjects who are willing to participate in the optional biorepository

Первичные конечные точки

• SLE epidemiology and presentation, [Срок оценки: Every 6 months for 10 years]
• SLE management, and outcomes [Срок оценки: Every 6 months for 10 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• CorEvitas — Waltham

Идентификаторы

NCT: NCT06804057 · CorEvitas-SLE-800

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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