NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Interventions: Standard of Care

Countries: United States, Australia, Canada, France, Germany, Italy, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (135)

Phoenix, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Beverly Hills, California, United States
El Cajon, California, United States
Loma Linda, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
San Francisco, California, United States
West Hills, California, United States
Miami, Florida, United States
Tamarac, Florida, United States
Coeur d'Alene, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Nashua, New Hampshire, United States
Newark, New Jersey, United States
Great Neck, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Salisbury, North Carolina, United States
Duncansville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
The Woodlands, Texas, United States
+ 105 more on CT.gov