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

Systemic Lupus Erythematosus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189875
• Other study ID #: D3461R00001
• Status: Completed
• Start date: June 28, 2017
• Est. completion date: November 18, 2022

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: November 18, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• Standard of Care
Participants will be followed as per local routine clinical practice

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity	Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score and score change from Baseline in patients with high and/or low status interferon 1 gene signature at Baseline after 6, 12, 18, 24, 30 and 36 months of follow-up.	6, 12, 18, 24, 30 and 36 months of follow-up
Primary	Healthcare resource utilization including direct and indirect costs	Mean annual global healthcare cost related to SLE in patients with high and/or low status interferon 1 gene signature at Baseline after 12, 24 and 36 months of follow-up.	12, 24 and 36 months of follow-up
Primary	Patient reported health outcomes	Total 36-Item Short Form Health Survey (SF-36) score and score change from Baseline in Physical Component Score (PCS) and Mental Component Score (MCS) in patients with high and/or low status interferon 1 gene signature after 6, 12, 18, 24, 30 and 36 months of follow-up. SF-36 survey covers eight domains of well-being: physical functioning, role limitations, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health combined into PCS and MCS, two summary scores of SF-36 survey.	6, 12, 18, 24, 30 and 36 months of follow-up
Primary	Organ damage burden	Mean score for Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI) and change from Baseline in SLICC/ACR DI for total score and individual components scores in patients with high and/or low status interferon 1 gene signature at Baseline after 12, 24 and 36 months of follow-up	12, 24 and 36 months of follow-up
Primary	Medical events of special interest	Incidence and prevalence of individual medical events of special interest in patients with high and/or low status interferon 1 gene signature at Baseline after 12, 24 and 36 months of follow-up.	up to 36 months

External Links

•   CSR Synopsis