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

Completed

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT03189875

Run by

AstraZeneca

People needed

830

Starts

2017-06-28

Expected to finish

2022-11-18

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Beverly Hills, California, United States
• Research Site — El Cajon, California, United States
• Research Site — Loma Linda, California, United States
• Research Site — Los Alamitos, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — San Francisco, California, United States
• Research Site — West Hills, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Tamarac, Florida, United States
• Research Site — Coeur d'Alene, Idaho, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Nashua, New Hampshire, United States
• Research Site — Newark, New Jersey, United States
• Research Site — Great Neck, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Greensboro, North Carolina, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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