{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T08:37:23Z","timestamp":1785227843544,"version":"3.55.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2018,12,1]],"date-time":"2018-12-01T00:00:00Z","timestamp":1543622400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2018,12,20]],"date-time":"2018-12-20T00:00:00Z","timestamp":1545264000000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000069","name":"National Institute of Arthritis and Musculoskeletal and Skin Diseases","doi-asserted-by":"publisher","award":["U01AR071077"],"award-info":[{"award-number":["U01AR071077"]}],"id":[{"id":"10.13039\/100000069","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000069","name":"National Institute of Arthritis and Musculoskeletal and Skin Diseases","doi-asserted-by":"publisher","award":["U34AR067392"],"award-info":[{"award-number":["U34AR067392"]}],"id":[{"id":"10.13039\/100000069","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000069","name":"National Institute of Arthritis and Musculoskeletal and Skin Diseases","doi-asserted-by":"publisher","award":["R01072401"],"award-info":[{"award-number":["R01072401"]}],"id":[{"id":"10.13039\/100000069","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000069","name":"National Institute of Arthritis and Musculoskeletal and Skin Diseases","doi-asserted-by":"publisher","award":["P30AR053483"],"award-info":[{"award-number":["P30AR053483"]}],"id":[{"id":"10.13039\/100000069","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","award":["UL1TR001105"],"award-info":[{"award-number":["UL1TR001105"]}],"id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000057","name":"National Institute of General Medical Sciences","doi-asserted-by":"publisher","award":["U54104938"],"award-info":[{"award-number":["U54104938"]}],"id":[{"id":"10.13039\/100000057","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2018,12]]},"DOI":"10.1186\/s13063-018-3076-7","type":"journal-article","created":{"date-parts":[[2018,12,20]],"date-time":"2018-12-20T14:52:23Z","timestamp":1545317543000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6588-3364","authenticated-orcid":false,"given":"Nancy J.","family":"Olsen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith A.","family":"James","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Arriens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariko L.","family":"Ishimori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J.","family":"Wallace","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane L.","family":"Kamen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin F.","family":"Chong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Duanping","family":"Liao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vernon M.","family":"Chinchilli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Karp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2018,12,20]]},"reference":[{"issue":"Suppl 4","key":"3076_CR1","doi-asserted-by":"publisher","first-page":"S4","DOI":"10.1186\/ar3919","volume":"14","author":"A Lateef","year":"2012","unstructured":"Lateef A, Petri M. Unmet medical needs in systemic lupus erythematosus. Arthritis Res Ther. 2012;14(Suppl 4):S4.","journal-title":"Arthritis Res Ther"},{"issue":"2","key":"3076_CR2","doi-asserted-by":"publisher","first-page":"R38","DOI":"10.1186\/ar3271","volume":"13","author":"QZ Li","year":"2011","unstructured":"Li QZ, Karp DR, Quan J, Branch VK, Zhou J, Lian Y, et al. Risk factors for ANA positivity in healthy persons. Arthritis Res Ther. 2011;13(2):R38.","journal-title":"Arthritis Res Ther"},{"issue":"16","key":"3076_CR3","doi-asserted-by":"publisher","first-page":"1526","DOI":"10.1056\/NEJMoa021933","volume":"349","author":"M Arbuckle","year":"2003","unstructured":"Arbuckle M, McClain M, Rubertone M, Scofield R, Dennis G, James J, et al. Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N Engl J Med. 2003;349(16):1526\u201333.","journal-title":"N Engl J Med"},{"issue":"3","key":"3076_CR4","doi-asserted-by":"publisher","first-page":"181","DOI":"10.1038\/nrrheum.2013.184","volume":"10","author":"NJ Olsen","year":"2014","unstructured":"Olsen NJ, Karp DR. Autoantibodies and SLE: the threshold for disease. Nat Rev Rheumatol. 2014;10(3):181\u20136.","journal-title":"Nat Rev Rheumatol"},{"issue":"3","key":"3076_CR5","doi-asserted-by":"publisher","first-page":"630","DOI":"10.1002\/art.40004","volume":"69","author":"ME Munroe","year":"2017","unstructured":"Munroe ME, Young KA, Kamen DL, Guthridge JM, Niewold TB, Costenbader KH, et al. Discerning risk of disease transition in relatives of systemic lupus erythematosus patients utilizing soluble mediators and clinical features. Arthritis Rheumatol. 2017;69(3):630\u201342.","journal-title":"Arthritis Rheumatol"},{"issue":"4","key":"3076_CR6","doi-asserted-by":"publisher","first-page":"R174","DOI":"10.1186\/ar3927","volume":"14","author":"NJ Olsen","year":"2012","unstructured":"Olsen NJ, Li QZ, Quan J, Wang L, Mutwally A, Karp DR. Autoantibody profiling to follow evolution of lupus syndromes. Arthritis Res Ther. 2012;14(4):R174.","journal-title":"Arthritis Res Ther"},{"key":"3076_CR7","doi-asserted-by":"publisher","first-page":"182","DOI":"10.1016\/j.jaut.2016.06.001","volume":"74","author":"R Lu","year":"2016","unstructured":"Lu R, Munroe ME, Guthridge JM, Bean KM, Fife DA, Chen H, et al. Dysregulation of innate and adaptive serum mediators precedes systemic lupus erythematosus classification and improves prognostic accuracy of autoantibodies. J Autoimmun. 2016;74:182\u201393.","journal-title":"J Autoimmun"},{"issue":"6","key":"3076_CR8","doi-asserted-by":"publisher","first-page":"401","DOI":"10.1177\/0961203307078579","volume":"16","author":"JA James","year":"2007","unstructured":"James JA, Kim-Howard XR, Bruner BF, Jonsson MK, McClain MT, Arbuckle MR, et al. Hydroxychloroquine sulfate treatment is associated with later onset of systemic lupus erythematosus. Lupus. 2007;16(6):401\u20139.","journal-title":"Lupus"},{"key":"3076_CR9","doi-asserted-by":"publisher","first-page":"30","DOI":"10.3899\/jrheum.120157","volume":"40","author":"A Broder","year":"2012","unstructured":"Broder A, Putterman C. Hydroxychloroquine use is associated with lower odds of persistently positive antiphospholipid antibodies and\/or lupus anticoagulant in systemic lupus erythematosus. J Rheumatol. 2012;40:30\u20133.","journal-title":"J Rheumatol"},{"issue":"8","key":"3076_CR10","doi-asserted-by":"publisher","first-page":"2677","DOI":"10.1002\/art.34473","volume":"64","author":"M Petri","year":"2012","unstructured":"Petri M, Orbai AM, Alarc\u00f3n GS, Gordon C, Merrill JT, Fortin PR, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012;64(8):2677\u201386.","journal-title":"Arthritis Rheum"},{"issue":"4","key":"3076_CR11","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1016\/1047-2797(94)00096-C","volume":"5","author":"EW Karlson","year":"1995","unstructured":"Karlson EW, Sanchez-Guerrero J, Wright EA, Lew RA, Daltroy LH, Katz JN, et al. A connective tissue disease screening questionnaire for population studies. Ann Epidemiol. 1995;5(4):297\u2013302.","journal-title":"Ann Epidemiol"},{"issue":"5","key":"3076_CR12","doi-asserted-by":"publisher","first-page":"889","DOI":"10.1111\/j.0022-202X.2005.23889.x","volume":"125","author":"J Albrecht","year":"2005","unstructured":"Albrecht J, Taylor L, Berlin JA, Dulay S, Ang G, Fakharzadeh S, et al. The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index): an outcome instrument for cutaneous lupus erythematosus. J Invest Dermatol. 2005;125(5):889\u201394.","journal-title":"J Invest Dermatol"},{"issue":"3","key":"3076_CR13","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1002\/art.1780390303","volume":"39","author":"D Gladman","year":"1996","unstructured":"Gladman D, Ginzler E, Goldsmith C, Fortin P, Liang M, Urowitz M, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics\/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996;39(3):363\u20139.","journal-title":"Arthritis Rheum"},{"issue":"2","key":"3076_CR14","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","volume":"42","author":"PA Harris","year":"2009","unstructured":"Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)\u2014a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377\u201381.","journal-title":"J Biomed Inform"},{"issue":"1","key":"3076_CR15","doi-asserted-by":"publisher","first-page":"57","DOI":"10.2307\/2529588","volume":"34","author":"RL Prentice","year":"1978","unstructured":"Prentice RL, Gloeckler LA. Regression analysis of grouped survival data with application to breast cancer data. Biometrics. 1978;34(1):57\u201367.","journal-title":"Biometrics"},{"issue":"3","key":"3076_CR16","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1016\/j.jaut.2006.09.001","volume":"27","author":"A Wandstrat","year":"2006","unstructured":"Wandstrat A, Carr-Johnson F, Branch V, Gray H, Fairhurst A, Reimold A, et al. Autoantibody profiling to identify individuals at risk for systemic lupus erythematosus. J Autoimmun. 2006;27(3):153\u201360.","journal-title":"J Autoimmun"},{"issue":"2","key":"3076_CR17","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1186\/ar3282","volume":"13","author":"DS Pisetsky","year":"2011","unstructured":"Pisetsky DS. Antinuclear antibodies in healthy people: the tip of autoimmunity's iceberg? Arthritis Res Ther. 2011;13(2):109.","journal-title":"Arthritis Res Ther"},{"issue":"11","key":"3076_CR18","doi-asserted-by":"publisher","first-page":"2473","DOI":"10.1001\/archinte.1989.00390110061013","volume":"149","author":"JM Greer","year":"1989","unstructured":"Greer JM, Panush RS. Incomplete lupus erythematosus. Arch Intern Med. 1989;149(11):2473\u20136.","journal-title":"Arch Intern Med"},{"issue":"1","key":"3076_CR19","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1111\/j.1365-2249.2006.03251.x","volume":"147","author":"Q Li","year":"2007","unstructured":"Li Q, Zhou J, Wandstrat A, Carr-Johnson F, Branch V, Karp D, et al. Protein array autoantibody profiles for insights into systemic lupus erythematosus and incomplete lupus syndromes. Clin Exp Immunol. 2007;147(1):60\u201370.","journal-title":"Clin Exp Immunol"},{"issue":"3","key":"3076_CR20","doi-asserted-by":"publisher","first-page":"281","DOI":"10.1111\/j.1365-2249.2009.04057.x","volume":"159","author":"Q Li","year":"2010","unstructured":"Li Q, Zhou J, Lian Y, Zhang B, Branch V, Carr-Johnson F, et al. Interferon signature gene expression is correlated with autoantibody profiles in patients with incomplete lupus syndromes. Clin Exp Immunol. 2010;159(3):281\u201391.","journal-title":"Clin Exp Immunol"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-018-3076-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-018-3076-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-018-3076-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,8]],"date-time":"2022-09-08T21:49:18Z","timestamp":1662673758000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-018-3076-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,12]]},"references-count":20,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["3076"],"URL":"https:\/\/doi.org\/10.1186\/s13063-018-3076-7","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,12]]},"assertion":[{"value":"18 August 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 November 2018","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 December 2018","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study protocol has been approved by the Institutional Review Boards of each institution: Penn State MS Hershey Medical Center, University of Texas Southwestern Medical Center, Oklahoma Medical Research Foundation, Cedars-Sinai Medical Center and Medical University of South Carolina.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"694"}}