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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03189875




Registration number
NCT03189875
Ethics application status
Date submitted
24/05/2017
Date registered
16/06/2017
Date last updated
2/07/2020

Titles & IDs
Public title
Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)
Scientific 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
Secondary ID [1] 0 0
D3461R00001
Universal Trial Number (UTN)
Trial acronym
SPOCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Standard of Care

Observation - Cohort of patients with moderate-to-severe SLE


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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6, 12, 18, 24, 30 and 36 months of follow-up
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
12, 24 and 36 months of follow-up
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
6, 12, 18, 24, 30 and 36 months of follow-up
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
12, 24 and 36 months of follow-up
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
up to 36 months

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Austl. Cap. Terr.NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Canberra
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Research Site - Camperdown
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Research Site - Liverpool
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Research Site - New Lambton Heights
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Research Site - Herston
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Research Site - Woodville South
Recruitment hospital [7] 0 0
Research Site - Clayton
Recruitment hospital [8] 0 0
Research Site - Fitzroy
Recruitment hospital [9] 0 0
Research Site - Footscray
Recruitment hospital [10] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3011 - Footscray
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
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Arizona
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Indiana
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Michigan
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03189875
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
Country 0 0
Phone 0 0
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Email 0 0
Contact person for public queries
Name 0 0
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Summary results
Other publications