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

SPOCS is an international, multicenter, prospective observational cohort study with bi-annual
follow-up over 3-years maximum follow-up of patients with SLE confirmed by American College
of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC)
classification criteria, who have moderate-to-severe disease by SLEDAI-2K criteria (Modified
SLEDAI-2K score ≥4 and/or SLEDAI-2K score ≥6 points, at least one life-time positive serology
of anti-nuclear antibody (ANA) or double-stranded deoxyribonucleic acid antibody (dsDNA), and
6-month minimum treatment duration with systemic SLE treatment beyond NSAIDS and analgesics.
Participants will be followed as per local routine clinical practice. SPOCS is an
observational study with no requirement for protocolized treatment interventions.

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