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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Other: Standard of Care

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.

• Study Type: Observational
• Enrollment (Actual): 830

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2605
      • Research Site
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Research Site
    • Liverpool, New South Wales, Australia, 2170
      • Research Site
    • New Lambton Heights, New South Wales, Australia, 2305
      • Research Site
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Research Site
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • Research Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Research Site
    • Fitzroy, Victoria, Australia, 3065
      • Research Site
    • Footscray, Victoria, Australia, 3011
      • Research Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Research Site
    • Edmonton, Alberta, Canada, T6G 2B7
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, 5Z 1L7
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Research Site
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Research Site
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Research Site
    • London, Ontario, Canada, N6A 5W9
      • Research Site
    • London, Ontario, Canada, N6A 5A5
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Research Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Research Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Research Site
    • Montreal, Quebec, Canada, H3T 1E2
      • Research Site
    • Ste-Foy, Quebec, Canada, G1V 4G2
      • Research Site
• France
  • Paris, France, 75012
    • Research Site
  • Bas Rhin
    • Strasbourg cedex, Bas Rhin, France, 67091
      • Research Site
  • Calvados
    • Caen cedex 9, Calvados, France, 14033
      • Research Site
  • Essonne
    • Corbeil-Essonnes, Essonne, France, 91100
      • Research Site
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Research Site
    • Pessac, Gironde, France, 33604
      • Research Site
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • Research Site
  • Loire Atlantique
    • Nantes Cedex 1, Loire Atlantique, France, 44093
      • Research Site
  • Lot
    • Cahors, Lot, France, 46000
      • Research Site
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49100
      • Research Site
  • Moselle
    • Vantoux, Moselle, France, 57070
      • Research Site
  • Nord
    • Lille, Nord, France, 59037
      • Research Site
  • Paris
    • Paris cedex 14, Paris, France, 75679
      • Research Site
  • Rhone
    • Lyon, Rhone, France, 69437
      • Research Site
    • Lyon cedex 03, Rhone, France, 69437
      • Research Site
  • Seine Maritime
    • Rouen Cedex, Seine Maritime, France, 76031
      • Research Site
• Germany
  • Berlin, Germany, 10117
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Baden Wuerttemberg
    • Heidelberg, Baden Wuerttemberg, Germany, 69120
      • Research Site
    • Stuttgart, Baden Wuerttemberg, Germany, 70376
      • Research Site
  • Bayern
    • Muenchen, Bayern, Germany, 80336
      • Research Site
    • Wuerzburg, Bayern, Germany, 97080
      • Research Site
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • Research Site
  • Mecklenburg Vorpommern
    • Bad Doberan, Mecklenburg Vorpommern, Germany, 18209
      • Research Site
  • Niedersachsen
    • Goettingen, Niedersachsen, Germany, 37075
      • Research Site
  • Nordrhein Westfalen
    • Wuppertal, Nordrhein Westfalen, Germany, 42105
      • Research Site
  • Rheinland Pfalz
    • Ludwigshafen, Rheinland Pfalz, Germany, 67063
      • Research Site
    • Mainz, Rheinland Pfalz, Germany, 55131
      • Research Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01067
      • Research Site
• Italy
  • Bologna, Italy, 40138
    • Research Site
  • Brescia, Italy, 25123
    • Research Site
  • Catania, Italy, 95124
    • Research Site
  • Firenze, Italy, 50139
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • LAquila, Italy, 67100
    • Research Site
  • Milano, Italy, 20122
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Pisa, Italy, 56100
    • Research Site
  • Torino, Italy, 20900
    • Research Site
  • Milano
    • Monza, Milano, Italy, 20900
      • Research Site
    • Rozzano, Milano, Italy, 20089
      • Research Site
  • Roma
    • Rome, Roma, Italy, 00168
      • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08041
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Barcelona, Spain, 08025
    • Research Site
  • Granada, Spain, 18016
    • Research Site
  • La Coruña, Spain, 15006
    • Research Site
  • Salamanca, Spain, 37007
    • Research Site
  • Sevilla, Spain, 41010
    • Research Site
  • Valladolid, Spain, 47005
    • Research Site
  • Valladolid, Spain, 47012
    • Research Site
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01009
      • Research Site
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Research Site
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Research Site
  • Cantabria
    • Torrelavega, Cantabria, Spain, 39300
      • Research Site
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Research Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
      • Research Site
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Research Site
• United Kingdom
  • Cheshire
    • Warrington, Cheshire, United Kingdom, WA5 1QG
      • Research Site
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Research Site
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Research Site
    • Eastbourne, East Sussex, United Kingdom, BN21 2UD
      • Research Site
  • Essex
    • Harlow, Essex, United Kingdom, CM20 1QX
      • Research Site
  • Greater London
    • London, Greater London, United Kingdom, SE1 7EH
      • Research Site
    • London, Greater London, United Kingdom, NW1 2PG
      • Research Site
    • London, Greater London, United Kingdom, SW170QT
      • Research Site
  • Kent
    • Maidstone, Kent, United Kingdom, ME16 9QQ
      • Research Site
  • Lancashire
    • Wigan, Lancashire, United Kingdom, WN6 9EP
      • Research Site
  • Lothian Region
    • Edinburgh, Lothian Region, United Kingdom, EH4 2XU
      • Research Site
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L9 7AL
      • Research Site
  • Somerset
    • Bath, Somerset, United Kingdom, BA15SW
      • Research Site
  • South Yorkshire
    • Barnsley, South Yorkshire, United Kingdom, S75 2EP
      • Research Site
    • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
      • Research Site
  • Staffordshire
    • Stoke on Trent, Staffordshire, United Kingdom, ST6 7AG
      • Research Site
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • Research Site
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • Research Site
    • Sheffield, West Midlands, United Kingdom, S10 2JF
      • Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85037
      • Research Site
    • Tucson, Arizona, United States, 85724
      • Research Site
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Research Site
  • California
    • Beverly Hills, California, United States, 90211
      • Research Site
    • El Cajon, California, United States, 92020
      • Research Site
    • Loma Linda, California, United States, 92354
      • Research Site
    • Los Alamitos, California, United States, 90720-5403
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Mission Viejo, California, United States, 92691
      • Research Site
    • San Francisco, California, United States, 94143
      • Research Site
    • West Hills, California, United States, 91307
      • Research Site
  • Florida
    • Miami, Florida, United States, 33126
      • Research Site
    • Tamarac, Florida, United States, 33321
      • Research Site
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Research Site
    • Baltimore, Maryland, United States, 21286
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Research Site
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Research Site
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Research Site
  • New York
    • Bronx, New York, United States, 10461
      • Research Site
    • Great Neck, New York, United States, 11021
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Research Site
    • Greensboro, North Carolina, United States, 27408
      • Research Site
    • Salisbury, North Carolina, United States, 28144
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15232
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Research Site
    • The Woodlands, Texas, United States, 77382
      • Research Site
  • Washington
    • Spokane, Washington, United States, 99204
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation; Cohort of patients with moderate-to-severe SLE	Other: Standard of Care; Participants will be followed as per local routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): November 18, 2022
• Study Completion (Actual): November 18, 2022

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus Disease
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: D3461R00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No