SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical features, disease progression and treatment patterns, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.

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.

The recruitment start and end dates are as follows:

Observational

You can take part if:

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

You may not be able to take part if:

This is in the inclusion criteria above

Below are the locations for where you can take part in the trial.

• Research Site
  Warrington
  Cheshire
  0
  
• Research Site
  Plymouth
  Devon
  0
  
• Research Site
  Brighton
  East Sussex
  0
  
• Research Site
  Eastbourne
  East Sussex
  0
  
• Research Site
  Harlow
  Essex
  0
  
• Research Site
  London
  Greater London
  0
  
• Research Site
  Maidstone
  Kent
  0
  
• Research Site
  Wigan
  Lancashire
  0
  
• Research Site
  Edinburgh
  Lothian Region
  0
  
• Research Site
  Liverpool
  Merseyside
  0
  
• Research Site
  Bath
  Somerset
  0
  
• Research Site
  Barnsley
  South Yorkshire
  0
  
• Research Site
  Doncaster
  South Yorkshire
  0
  
• Research Site
  Cannock
  Staffordshire
  0
  
• Research Site
  Stoke on Trent
  Staffordshire
  0
  
• Research Site
  Coventry
  Warwickshire
  0
  
• Research Site
  Dudley
  West Midlands
  0
  
• Research Site
  Sheffield
  West Midlands
  0
  

The study is sponsored by AstraZeneca .