We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03189875
Recruitment Status : Completed
First Posted : June 16, 2017
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 830 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : November 18, 2022
Actual Study Completion Date : November 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.


Biospecimen Retention:   Samples With DNA
type I IFN gene signature test (type 1 interferon gene test)

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189875


Locations
Show Show 136 study locations
Sponsors and Collaborators
AstraZeneca
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03189875    
Other Study ID Numbers: D3461R00001
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Systemic Lupus Erythematosus Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases