Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)
NCT ID: NCT03189875
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
830 participants
OBSERVATIONAL
2017-06-28
2022-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation
Cohort of patients with moderate-to-severe SLE
Standard of Care
Participants will be followed as per local routine clinical practice
Interventions
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Standard of Care
Participants will be followed as per local routine clinical practice
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Beverly Hills, California, United States
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El Cajon, California, United States
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Loma Linda, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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San Francisco, California, United States
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West Hills, California, United States
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Miami, Florida, United States
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Tamarac, Florida, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Nashua, New Hampshire, United States
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Newark, New Jersey, United States
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Great Neck, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Salisbury, North Carolina, United States
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Duncansville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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The Woodlands, Texas, United States
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Spokane, Washington, United States
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Canberra, Australian Capital Territory, Australia
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Camperdown, New South Wales, Australia
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Liverpool, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Herston, Queensland, Australia
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Woodville South, South Australia, Australia
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Clayton, Victoria, Australia
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Fitzroy, Victoria, Australia
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Footscray, Victoria, Australia
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Nedlands, Western Australia, Australia
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Strasbourg, Bas Rhin, France
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Caen, Calvados, France
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Corbeil-Essonnes, Essonne, France
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Bordeaux, Gironde, France
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Pessac, Gironde, France
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Montpellier, Herault, France
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Nantes, Loire Atlantique, France
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Cahors, Lot, France
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Angers, Maine Et Loire, France
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Vantoux, Moselle, France
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Lille, Nord, France
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Paris, Paris, France
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Lyon, Rhone, France
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Rouen, Seine Maritime, France
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Paris, , France
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Heidelberg, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Bad Nauheim, Hesse, Germany
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Göttingen, Lower Saxony, Germany
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Bad Doberan, Mecklenburg-Vorpommern, Germany
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Wuppertal, North Rhine-Westphalia, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
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Mainz, Rhineland-Palatinate, Germany
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Dresden, Saxony, Germany
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Berlin, , Germany
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Dresden, , Germany
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Monza, Milano, Italy
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Rozzano, Milano, Italy
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Rome, Roma, Italy
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Bologna, , Italy
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Brescia, , Italy
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Catania, , Italy
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Florence, , Italy
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Genova, , Italy
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LAquila, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Pisa, , Italy
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Torino, , Italy
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Vitoria-Gasteiz, Alava, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Torrelavega, Cantabria, Spain
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El Palmar, Murcia, Spain
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Vigo, Pontevedra, Spain
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Oviedo, Principality of Asturias, Spain
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Bilbao, Vizcaya, Spain
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Salamanca, , Spain
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Seville, , Spain
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Valladolid, , Spain
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Valladolid, , Spain
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Warrington, Cheshire, United Kingdom
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Plymouth, Devon, United Kingdom
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Brighton, East Sussex, United Kingdom
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Eastbourne, East Sussex, United Kingdom
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Harlow, Essex, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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Maidstone, Kent, United Kingdom
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Wigan, Lancashire, United Kingdom
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Edinburgh, Lothian Region, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Bath, Somerset, United Kingdom
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Barnsley, South Yorkshire, United Kingdom
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Doncaster, South Yorkshire, United Kingdom
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Stoke-on-Trent, Staffordshire, United Kingdom
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Coventry, Warwickshire, United Kingdom
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Dudley, West Midlands, United Kingdom
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Sheffield, West Midlands, United Kingdom
Countries
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References
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Aringer M, Arnaud L, Furie RA, Morand EF, Peschken C, Hoi A, Desta B, Hedberg J, Grunfeld Een T, Sorrentino A, Kielar D, Tummala R, Chen S, Ding B. Real-world treatment patterns and clinical characteristics in patients with moderate-to-severe systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS). Lupus Sci Med. 2025 Jan 23;12(1):e001336. doi: 10.1136/lupus-2024-001336.
Hammond ER, Tummala R, Berglind A, Syed F, Wang X, Desta B, Nab H. Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature. BMJ Open. 2020 Sep 1;10(9):e036563. doi: 10.1136/bmjopen-2019-036563.
Related Links
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Other Identifiers
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D3461R00001
Identifier Type: -
Identifier Source: org_study_id
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