Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)
SPOCS
1 other identifier
observational
830
8 countries
135
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Longer than P75 for all trials
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedStudy Start
First participant enrolled
June 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2022
CompletedFebruary 28, 2024
January 1, 2024
5.4 years
May 24, 2017
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
Observation
Cohort of patients with moderate-to-severe SLE
Interventions
Participants will be followed as per local routine clinical practice
Eligibility Criteria
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
You may qualify if:
- 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
- Patient and/or representative(s) who understands the requirements of the study and provides written informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (135)
Research Site
Phoenix, Arizona, 85037, United States
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Tucson, Arizona, 85724, United States
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Jonesboro, Arkansas, 72401, United States
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Beverly Hills, California, 90211, United States
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El Cajon, California, 92020, United States
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Loma Linda, California, 92354, United States
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Los Alamitos, California, 90720-5403, United States
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Los Angeles, California, 90095, United States
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Mission Viejo, California, 92691, United States
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San Francisco, California, 94143, United States
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West Hills, California, 91307, United States
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Miami, Florida, 33126, United States
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Tamarac, Florida, 33321, United States
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Coeur d'Alene, Idaho, 83814, United States
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Chicago, Illinois, 60612, United States
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Indianapolis, Indiana, 46202, United States
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Baltimore, Maryland, 21218, United States
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Baltimore, Maryland, 21286, United States
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Detroit, Michigan, 48202, United States
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Nashua, New Hampshire, 03060, United States
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Newark, New Jersey, 07103, United States
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Great Neck, New York, 11021, United States
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The Bronx, New York, 10461, United States
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Durham, North Carolina, 27710, United States
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Greensboro, North Carolina, 27408, United States
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Salisbury, North Carolina, 28144, United States
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Duncansville, Pennsylvania, 16635, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Dallas, Texas, 75231, United States
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The Woodlands, Texas, 77382, United States
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Spokane, Washington, 99204, United States
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Canberra, Australian Capital Territory, 2605, Australia
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Camperdown, New South Wales, 2050, Australia
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Liverpool, New South Wales, 2170, Australia
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New Lambton Heights, New South Wales, 2305, Australia
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Herston, Queensland, 4029, Australia
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Woodville South, South Australia, 5011, Australia
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Clayton, Victoria, 3168, Australia
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Fitzroy, Victoria, 3065, Australia
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Footscray, Victoria, 3011, Australia
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Nedlands, Western Australia, 6009, Australia
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, 5Z 1L7, Canada
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Winnipeg, Manitoba, R3A 1M3, Canada
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Winnipeg, Manitoba, R3A 1M4, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Barrie, Ontario, L4M 6L2, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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London, Ontario, N6A 5A5, Canada
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London, Ontario, N6A 5W9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Ste-Foy, Quebec, G1V 4G2, Canada
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Strasbourg, Bas Rhin, 67091, France
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Caen, Calvados, 14033, France
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Corbeil-Essonnes, Essonne, 91100, France
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Bordeaux, Gironde, 33000, France
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Pessac, Gironde, 33604, France
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Montpellier, Herault, 34295, France
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Nantes, Loire Atlantique, 44093, France
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Cahors, Lot, 46000, France
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Angers, Maine Et Loire, 49100, France
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Vantoux, Moselle, 57070, France
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Lille, Nord, 59037, France
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Paris, Paris, 75679, France
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Lyon, Rhone, 69437, France
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Rouen, Seine Maritime, 76031, France
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Paris, 75012, France
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Heidelberg, Baden-Wurttemberg, 69120, Germany
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Stuttgart, Baden-Wurttemberg, 70376, Germany
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Munich, Bavaria, 80336, Germany
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Würzburg, Bavaria, 97080, Germany
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Bad Nauheim, Hesse, 61231, Germany
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Göttingen, Lower Saxony, 37075, Germany
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Bad Doberan, Mecklenburg-Vorpommern, 18209, Germany
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Wuppertal, North Rhine-Westphalia, 42105, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Dresden, Saxony, 01067, Germany
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Berlin, 10117, Germany
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Dresden, 01307, Germany
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Monza, Milano, 20900, Italy
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Rozzano, Milano, 20089, Italy
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Rome, Roma, 00168, Italy
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Catania, 95124, Italy
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Florence, 50139, Italy
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Genova, 16132, Italy
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LAquila, 67100, Italy
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Milan, 20122, Italy
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Milan, 20132, Italy
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Napoli, 80131, Italy
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Pisa, 56100, Italy
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Torino, 20900, Italy
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Vitoria-Gasteiz, Alava, 01009, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Torrelavega, Cantabria, 39300, Spain
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El Palmar, Murcia, 30120, Spain
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Vigo, Pontevedra, 36214, Spain
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Oviedo, Principality of Asturias, 33011, Spain
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Bilbao, Vizcaya, 48013, Spain
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A Coruña, 15006, Spain
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Barcelona, 08003, Spain
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Barcelona, 08025, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08041, Spain
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Granada, 18016, Spain
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Salamanca, 37007, Spain
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Seville, 41010, Spain
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Valladolid, 47005, Spain
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Valladolid, 47012, Spain
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Warrington, Cheshire, WA5 1QG, United Kingdom
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Plymouth, Devon, PL6 8DH, United Kingdom
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Brighton, East Sussex, BN2 5BE, United Kingdom
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Eastbourne, East Sussex, BN21 2UD, United Kingdom
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Harlow, Essex, CM20 1QX, United Kingdom
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London, Greater London, NW1 2PG, United Kingdom
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London, Greater London, SE1 7EH, United Kingdom
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London, Greater London, SW170QT, United Kingdom
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Maidstone, Kent, ME16 9QQ, United Kingdom
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Wigan, Lancashire, WN6 9EP, United Kingdom
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Edinburgh, Lothian Region, EH4 2XU, United Kingdom
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Liverpool, Merseyside, L9 7AL, United Kingdom
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Bath, Somerset, BA15SW, United Kingdom
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Barnsley, South Yorkshire, S75 2EP, United Kingdom
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Doncaster, South Yorkshire, DN2 5LT, United Kingdom
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Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom
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Coventry, Warwickshire, CV2 2DX, United Kingdom
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Dudley, West Midlands, DY1 2HQ, United Kingdom
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Sheffield, West Midlands, S10 2JF, United Kingdom
Related Publications (3)
Morand EF, Furie R, Aringer M, Arnaud L, Peschken C, Hoi A, Lee KW, Hedberg J, Grunfeld Een T, Tummala R, Chen S, Ding B. Disease progression in patients with systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS). Rheumatology (Oxford). 2025 Nov 11:keaf599. doi: 10.1093/rheumatology/keaf599. Online ahead of print.
PMID: 41217773DERIVEDAringer 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.
PMID: 39855677DERIVEDHammond 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.
PMID: 32873668DERIVED
Related Links
Biospecimen
type I IFN gene signature test (type 1 interferon gene test)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2017
First Posted
June 16, 2017
Study Start
June 28, 2017
Primary Completion
November 18, 2022
Study Completion
November 18, 2022
Last Updated
February 28, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.