For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Patients must meet the following criteria for enrollment in SPOCS:

  1. Adult patients aged 18 years or older
  2. Physician confirmation that patient meets ACR or SLICC SLE classification criteria
  3. Current or historic positive serology of ANA or dsDNA
  4. Minimum treatment duration of 6 months for active SLE with systemic SLE treatment beyond NSAIDs and analgesics
  5. 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.
  6. 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:

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

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Systemic Lupus Erythematosus

Age

18+

Participants needed

830

Est. Completion Date

Dec 2022

Treatment type

Observational


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT03189875

Study number

D3461R00001

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