Last updated on October 2018

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


Brief description of 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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03189875

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