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

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT03189875

Acronym / sponsor ID

SPOCS / D3461R00001

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus Disease

Study type

Observational

Recruitment status

Completed

Enrolment

830 participants (actual)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Study start

28 Jun 2017 (actual)

Primary completion

18 Nov 2022 (actual)

Study completion

18 Nov 2022 (actual)

First posted

16 Jun 2017 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 to 130 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
• Derived from this study: PubMed 42463277Lozano-Rivas N, Rua-Figueroa I, Freire-Gonzalez M, Turrion A, Castellvi I, Barbado Ajo J, Calvo-Alen J, Ortego-Centeno N, Diaz-Encarnacion M, Pego-Reigosa JM, Ding B, Galvez-Fernandez M, Bahamontes-Rosa N, Cervera R; Spanish SLE Prospective Observational Cohort Study (SPOCS). Real-world treatment patterns and outcomes in moderate-to-severe SLE: findings from the Spanish SPOCS cohort. Lupus Sci Med. 2026 Jul 16;13(2):e002054. doi: 10.1136/lupus-2026-002054.
• Derived from this study: PubMed 41217773Morand EF, Furie R, Aringer M, Arnaud L, Peschken C, Hoi A, Lee KW, Hedberg J, Grunfeld Een T, Tummala R, Chen S, Ding B. Disease progression in patients with systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS). Rheumatology (Oxford). 2026 Feb 4;65(2):keaf599. doi: 10.1093/rheumatology/keaf599.
• Derived from this study: PubMed 39855677Aringer M, Arnaud L, Furie RA, Morand EF, Peschken C, Hoi A, Desta B, Hedberg J, Grunfeld Een T, Sorrentino A, Kielar D, Tummala R, Chen S, Ding B. Real-world treatment patterns and clinical characteristics in patients with moderate-to-severe systemic lupus erythematosus: an analysis of the SLE Prospective Observational Cohort Study (SPOCS). Lupus Sci Med. 2025 Jan 23;12(1):e001336. doi: 10.1136/lupus-2024-001336.
• Derived from this study: PubMed 32873668Hammond ER, Tummala R, Berglind A, Syed F, Wang X, Desta B, Nab H. Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature. BMJ Open. 2020 Sep 1;10(9):e036563. doi: 10.1136/bmjopen-2019-036563.
• CSR SynopsisLink provided by the sponsor.
• Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

135 sites in 8 countries: see every site and its status.