Clinical trial NCT03189875: Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)
Official title: Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS): Prospective Observational Cohort of Patients With Moderate-to-severe SLE to Characterize Cross-sectional and Longitudinal Disease Activity, Treatment Patterns and Effectiveness, Outcomes and Comorbidities, Healthcare Resource Utilization, and the Impact of SLE on Quality of Life by Type I Interferon Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of SLE confirmed by ACR or SLICC classification criteria with moderate-to-severe disease by SLEDAI-2K criteria (Modified SLEDAI-2K score ≥4 or SLEDAI-2K score ≥6 points), a historic or current positive serology for ANA or dsDNA, and a 6-month minimum treatment duration with systemic SLE treatment beyond NSAIDS and analgesics

Brief summary: 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 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.

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

Primary outcomes:
measure: Disease activity
timeFrame: 6, 12, 18, 24, 30 and 36 months of follow-up
measure: Healthcare resource utilization including direct and indirect costs
timeFrame: 12, 24 and 36 months of follow-up
measure: Patient reported health outcomes
timeFrame: 6, 12, 18, 24, 30 and 36 months of follow-up
measure: Organ damage burden
timeFrame: 12, 24 and 36 months of follow-up
measure: Medical events of special interest
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Jonesboro
country: United States
facility: Research Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: El Cajon
country: United States
facility: Research Site
state: California
city: Loma Linda
country: United States
facility: Research Site
state: California
city: Los Alamitos
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: West Hills
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Tamarac
country: United States
facility: Research Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
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state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Baltimore
country: United States
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state: Maryland
city: Baltimore
country: United States
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state: Maryland
city: Detroit
country: United States
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state: Michigan
city: Nashua
country: United States
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state: New Hampshire
city: Newark
country: United States
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state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: Great Neck
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
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state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Salisbury
country: United States
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state: North Carolina
city: Duncansville
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Dallas
country: United States
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state: Texas
city: The Woodlands
country: United States
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state: Texas
city: Spokane
country: United States
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state: Washington
city: Canberra
country: Australia
facility: Research Site
state: Australian Capital Territory
city: Camperdown
country: Australia
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state: New South Wales
city: Liverpool
country: Australia
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state: New South Wales
city: New Lambton Heights
country: Australia
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state: New South Wales
city: Herston
country: Australia
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state: Queensland
city: Woodville South
country: Australia
facility: Research Site
state: South Australia
city: Clayton
country: Australia
facility: Research Site
state: Victoria
city: Fitzroy
country: Australia
facility: Research Site
state: Victoria
city: Footscray
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
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state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
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state: Manitoba
city: Winnipeg
country: Canada
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state: Manitoba
city: Halifax
country: Canada
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state: Nova Scotia
city: Barrie
country: Canada
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state: Ontario
city: Hamilton
country: Canada
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state: Ontario
city: London
country: Canada
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state: Ontario
city: London
country: Canada
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state: Ontario
city: Ottawa
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Greenfield Park
country: Canada
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state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Ste-Foy
country: Canada
facility: Research Site
state: Quebec
city: Strasbourg cedex
country: France
facility: Research Site
state: Bas Rhin
city: Caen cedex 9
country: France
facility: Research Site
state: Calvados
city: Corbeil-Essonnes
country: France
facility: Research Site
state: Essonne
city: Bordeaux
country: France
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state: Gironde
city: Pessac
country: France
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state: Gironde
city: Montpellier Cedex 5
country: France
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state: Herault
city: Nantes Cedex 1
country: France
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state: Loire Atlantique
city: Cahors
country: France
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state: Lot
city: Angers
country: France
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state: Maine Et Loire
city: Vantoux
country: France
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state: Moselle
city: Lille
country: France
facility: Research Site
state: Nord
city: Paris cedex 14
country: France
facility: Research Site
state: Paris
city: Lyon cedex 03
country: France
facility: Research Site
state: Rhone
city: Lyon
country: France
facility: Research Site
state: Rhone
city: Rouen Cedex
country: France
facility: Research Site
state: Seine Maritime
city: Paris
country: France
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Stuttgart
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Muenchen
country: Germany
facility: Research Site
state: Bayern
city: Wuerzburg
country: Germany
facility: Research Site
state: Bayern
city: Bad Nauheim
country: Germany
facility: Research Site
state: Hessen
city: Bad Doberan
country: Germany
facility: Research Site
state: Mecklenburg Vorpommern
city: Goettingen
country: Germany
facility: Research Site
state: Niedersachsen
city: Wuppertal
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Ludwigshafen
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Mainz
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Monza
country: Italy
facility: Research Site
state: Milano
city: Rozzano
country: Italy
facility: Research Site
state: Milano
city: Rome
country: Italy
facility: Research Site
state: Roma
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Catania
country: Italy
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city: Firenze
country: Italy
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city: Genova
country: Italy
facility: Research Site
city: LAquila
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Vitoria-Gasteiz
country: Spain
facility: Research Site
state: Alava
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Torrelavega
country: Spain
facility: Research Site
state: Cantabria
city: El Palmar
country: Spain
facility: Research Site
state: Murcia
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: La Coruña
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Warrington
country: United Kingdom
facility: Research Site
state: Cheshire
city: Plymouth
country: United Kingdom
facility: Research Site
state: Devon
city: Brighton
country: United Kingdom
facility: Research Site
state: East Sussex
city: Eastbourne
country: United Kingdom
facility: Research Site
state: East Sussex
city: Harlow
country: United Kingdom
facility: Research Site
state: Essex
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: Maidstone
country: United Kingdom
facility: Research Site
state: Kent
city: Wigan
country: United Kingdom
facility: Research Site
state: Lancashire
city: Edinburgh
country: United Kingdom
facility: Research Site
state: Lothian Region
city: Liverpool
country: United Kingdom
facility: Research Site
state: Merseyside
city: Bath
country: United Kingdom
facility: Research Site
state: Somerset
city: Barnsley
country: United Kingdom
facility: Research Site
state: South Yorkshire
city: Doncaster
country: United Kingdom
facility: Research Site
state: South Yorkshire
city: Stoke on Trent
country: United Kingdom
facility: Research Site
state: Staffordshire
city: Coventry
country: United Kingdom
facility: Research Site
state: Warwickshire
city: Dudley
country: United Kingdom
facility: Research Site
state: West Midlands
city: Sheffield
country: United Kingdom
facility: Research Site
state: West Midlands
Study officials:
References:
citation: 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.