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

AstraZeneca

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Standard of Care

Study type: Observational

Funder types: Industry

Identifiers

NCT03189875

D3461R00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 830 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

830 participants in 1 patient group

Observation

Description:

Cohort of patients with moderate-to-severe SLE

Treatment:

Other: Standard of Care