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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03189875
Ethics application status
Date submitted
24/05/2017
Date registered
16/06/2017

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
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
Timepoint [2] 0 0
12, 24 and 36 months of follow-up
Primary outcome [3] 0 0
Patient reported health outcomes
Timepoint [3] 0 0
6, 12, 18, 24, 30 and 36 months of follow-up
Primary outcome [4] 0 0
Organ damage burden
Timepoint [4] 0 0
12, 24 and 36 months of follow-up
Primary outcome [5] 0 0
Medical events of special interest
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
18 Years
Maximum age
130 Years
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2022
Sample size
Target
Accrual to date
Final
830
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Canberra
Recruitment hospital [2] 0 0
Research Site - Camperdown
Recruitment hospital [3] 0 0
Research Site - Liverpool
Recruitment hospital [4] 0 0
Research Site - New Lambton Heights
Recruitment hospital [5] 0 0
Research Site - Herston
Recruitment hospital [6] 0 0
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
Country [1] 0 0
United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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Florida
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Idaho
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Illinois
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Indiana
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Maryland
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Michigan
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New Hampshire
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New Jersey
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New York
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North Carolina
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Pennsylvania
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Texas
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Washington
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Nova Scotia
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Ontario
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Quebec
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France
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Bas Rhin
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Gironde
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Herault
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France
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Loire Atlantique
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France
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Lot
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France
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Maine Et Loire
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France
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Moselle
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France
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Nord
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France
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Paris
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France
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Rhone
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France
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Seine Maritime
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Germany
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Baden Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Mecklenburg Vorpommern
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Germany
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Niedersachsen
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Germany
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Nordrhein Westfalen
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Germany
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Rheinland Pfalz
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Dresden
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Italy
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Milano
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Italy
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Roma
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Catania
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Italy
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Firenze
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Italy
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Genova
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Italy
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LAquila
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Italy
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Napoli
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Pisa
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Torino
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Alava
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Asturias
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Barcelona
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Cantabria
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Murcia
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Pontevedra
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Vizcaya
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Granada
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Spain
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La Coruña
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Salamanca
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Spain
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Sevilla
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Spain
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Valladolid
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United Kingdom
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Cheshire
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United Kingdom
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Devon
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United Kingdom
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East Sussex
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United Kingdom
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Essex
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United Kingdom
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Greater London
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United Kingdom
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Kent
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United Kingdom
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Lancashire
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United Kingdom
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Lothian Region
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United Kingdom
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Merseyside
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United Kingdom
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Somerset
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United Kingdom
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South Yorkshire
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United Kingdom
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Staffordshire
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United Kingdom
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Warwickshire
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United Kingdom
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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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03189875