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Contact Information:

Study Location:

Research Site
Warrington
Cheshire
0


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

Medical Conditions

Systemic Lupus Erythematosus


Study 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.

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.


Key dates

The recruitment start and end dates are as follows:

Jun 2017

Dec 2022

Study type

Observational

Intervention Type : Other
Intervention Name : Standard of Care
Intervention Description : Participants will be followed as per local routine clinical practice

Intervention Arm Group : Observation

Who can take part?

You can take part if:


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




You may not be able to take part if:

This is in the inclusion criteria above


Where can I take part?

Below are the locations for where you can take part in the trial.

  • Research Site
    Warrington
    Cheshire
    0
  • Research Site
    Plymouth
    Devon
    0
  • Research Site
    Brighton
    East Sussex
    0
  • Research Site
    Eastbourne
    East Sussex
    0
  • Research Site
    Harlow
    Essex
    0
  • Research Site
    London
    Greater London
    0
  • Research Site
    Maidstone
    Kent
    0
  • Research Site
    Wigan
    Lancashire
    0
  • Research Site
    Edinburgh
    Lothian Region
    0
  • Research Site
    Liverpool
    Merseyside
    0
  • Research Site
    Bath
    Somerset
    0
  • Research Site
    Barnsley
    South Yorkshire
    0
  • Research Site
    Doncaster
    South Yorkshire
    0
  • Research Site
    Cannock
    Staffordshire
    0
  • Research Site
    Stoke on Trent
    Staffordshire
    0
  • Research Site
    Coventry
    Warwickshire
    0
  • Research Site
    Dudley
    West Midlands
    0
  • Research Site
    Sheffield
    West Midlands
    0

Funders/Sponsors


The study is sponsored by AstraZeneca .



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for Trial ID: NCT03189875

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