Last updated on December 2019

Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

Patients must meet the following criteria for enrollment in SPOCS:

  • Adult patients aged 18 years or older
  • Physician confirmation that patient meets ACR or SLICC SLE classification criteria
  • Current or historic positive serology of ANA or dsDNA
  • Minimum treatment duration of 6 months for active SLE with systemic SLE treatment beyond NSAIDs and analgesics
  • Moderate-to-severe SLE; SLEDAI-2K Criteria: Modified SLEDAI-2K score 4 and/or SLEDAI-2K score 6. The "Modified" SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures and lupus headache.
  • Patient and/or representative(s) who understands the requirements of the study and provides written informed consent.

Exclusion Criteria:

Patients meeting any of the following criteria will be determined to be ineligible for enrollment in SPOCS:

  • Patients actively enrolled in interventional trials involving investigational agents
  • Patient with active severe lupus nephritis with a history of a renal biopsy in the last year showing active class III or class IV +/- class V lupus nephritis and/or urine protein:creatinine ratio >1mg/mg based on random urine collection.
  • Patients unable to complete study measures

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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