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

February 27, 2024 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
830

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 6, 12, 18, 24, 30 and 36 months of follow-up
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
Time Frame: 12, 24 and 36 months of follow-up
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
Time Frame: 6, 12, 18, 24, 30 and 36 months of follow-up
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
Time Frame: 12, 24 and 36 months of follow-up
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
Time Frame: up to 36 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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