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
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|Condition or disease||Intervention/treatment|
|Systemic Lupus Erythematosus||Other: Standard of Care|
|Study Type :||Observational|
|Actual Enrollment :||830 participants|
|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|
Cohort of patients with moderate-to-severe SLE
Other: Standard of Care
Participants will be followed as per local routine clinical practice
- 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.
- 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.
- 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.
- 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
- 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
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.
|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|
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.
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
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
|Other Study ID Numbers:||
|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|
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.
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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Systemic Lupus Erythematosus Disease
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases