Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature
Introduction The Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS) aims to describe the disease course of SLE and its association with type I interferon gene signature (IFNGS) status.Methods and analysis SPOCS is an international, multicentre, prospective, observation...
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BMJ Publishing Group
2020-09-01
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| author | Raj Tummala Anna Berglind Xia Wang Henk Nab Barnabas Desta Edward R Hammond Farhat Syed |
| author_facet | Raj Tummala Anna Berglind Xia Wang Henk Nab Barnabas Desta Edward R Hammond Farhat Syed |
| author_sort | Raj Tummala |
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| description | Introduction The Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS) aims to describe the disease course of SLE and its association with type I interferon gene signature (IFNGS) status.Methods and analysis SPOCS is an international, multicentre, prospective, observational cohort study designed to follow patients through biannual study visits during a 3-year observation period. Patients ≥18 years old with a physician diagnosis that meets the American College of Rheumatology or Systemic Lupus International Collaborating Clinics SLE classification criteria will be included. SPOCS will comprehensively analyse clinical features, disease progression and treatment, SLE outcomes, health status assessments and quality of life, and healthcare resource utilisation of patients with moderate to severe SLE. A four-gene test will be used to measure IFNGS status; scores will be compared with a pre-established cut-off. Patients will be stratified by low or high IFNGS expression levels. Enrolment began in June 2017, and study completion is expected in 2022. The total number of anticipated patients was initially planned for 1500 patients and was amended to 900 patients owing to slow accrual of eligible patients.Ethics and dissemination The ethics committee/institutional review board/independent ethics committee at each study site approved the SPOCS protocol prior to study initiation (protocol number: D3461R00001, version 3.0, 26 June 2019). Study findings will be disseminated through peer-reviewed publications and presentations at scientific meetings.Trial registration number NCT03189875. |
| format | Article |
| id | doaj-art-4cdc93df42c84d7b978b4070d53148a2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-4cdc93df42c84d7b978b4070d53148a22025-01-08T16:50:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-036563Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signatureRaj Tummala0Anna Berglind1Xia Wang2Henk Nab3Barnabas Desta4Edward R Hammond5Farhat Syed65AstraZeneca, Gaithersburg, MD, USABioPharmaceuticals, R&D, AstraZeneca, Gothenburg, SwedenData Science and AI, R&D, AstraZeneca, Gaithersburg, Maryland, USAInflammation and Autoimmunity, AstraZeneca, Cambridge, UK1AstraZeneca, Gaithersburg, MD, United States of AmericaBioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, USAPrecision Medicine, R&D, AstraZeneca, Cambridge, UKIntroduction The Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS) aims to describe the disease course of SLE and its association with type I interferon gene signature (IFNGS) status.Methods and analysis SPOCS is an international, multicentre, prospective, observational cohort study designed to follow patients through biannual study visits during a 3-year observation period. Patients ≥18 years old with a physician diagnosis that meets the American College of Rheumatology or Systemic Lupus International Collaborating Clinics SLE classification criteria will be included. SPOCS will comprehensively analyse clinical features, disease progression and treatment, SLE outcomes, health status assessments and quality of life, and healthcare resource utilisation of patients with moderate to severe SLE. A four-gene test will be used to measure IFNGS status; scores will be compared with a pre-established cut-off. Patients will be stratified by low or high IFNGS expression levels. Enrolment began in June 2017, and study completion is expected in 2022. The total number of anticipated patients was initially planned for 1500 patients and was amended to 900 patients owing to slow accrual of eligible patients.Ethics and dissemination The ethics committee/institutional review board/independent ethics committee at each study site approved the SPOCS protocol prior to study initiation (protocol number: D3461R00001, version 3.0, 26 June 2019). Study findings will be disseminated through peer-reviewed publications and presentations at scientific meetings.Trial registration number NCT03189875.https://bmjopen.bmj.com/content/10/9/e036563.full |
| spellingShingle | Raj Tummala Anna Berglind Xia Wang Henk Nab Barnabas Desta Edward R Hammond Farhat Syed 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 |
| title | Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature |
| title_full | Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature |
| title_fullStr | Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature |
| title_full_unstemmed | Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature |
| title_short | Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature |
| title_sort | study protocol for the international systemic lupus erythematosus prospective observational cohort study spocs understanding lupus and the role of type i interferon gene signature |
| url | https://bmjopen.bmj.com/content/10/9/e036563.full |
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