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A Study of Clinical Disease Flare Through Assessment of Systemic Lupus Erythematosus Patients

Overview

Información sobre este estudio

The purpose of this study is to focus on following a prospective cohort of 30 patients with classified SLE for the collection of demographic, clinical (disease activity), and laboratory data that can be used to provide well- characterized biological samples for future assessment of mechanisms of immune dysregulation that lead to clinical disease flare, including a distinct subset of SLE-associated, immune pathway alterations that inform a predictive algorithm. A successful outcome of this proposal will allow for the development of an optimized soluble mediator score, encompassing a distinct subset of informative biomarkers, ready for clinical testing.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Males or females age 18 orolder
  • Meet ≥ 4 ACR classification criteria for SLE (Appendix 2), by medical record review and/or clinical/laboratory assessmentOR
  • Meet ≥ 4 SLICC classification for SLE, including at least one clinical and one immunologic criteria (Appendix 3), by medical record review and/or clinical/laboratory assessmentOR
  • Meet SLE classification by SLICC (Appendix 3) with ANA positivity and renal biopsy-proven lupus nephritis
  • Have a clinical diagnosis of activeSLE
  • Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply withthe study data collectionprocedures

Exclusion Criteria:

  • Inability to comply with the study visit schedule andprocedures
  • Currently being treated withcyclophosphamide
  • Treated with rituximab within the last sixmonths
  • Exclusion at the discretion of rheumatologist due to disease severity

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Uma Thanarajasingam, M.D., Ph.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20405220

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