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

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-007054
    Sponsor Protocol Number: 17-007054

About this study

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.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Danielle Vsetecka

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20405220

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