{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T21:26:18Z","timestamp":1792531578918,"version":"4.5.0"},"reference-count":52,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,9,12]],"date-time":"2023-09-12T00:00:00Z","timestamp":1694476800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis Care &amp; Research"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Juvenile systemic sclerosis (SSc) is an orphan disease, associated with high morbidity and mortality. New treatment strategies are much needed, but clearly defining appropriate outcomes is necessary if successful therapies are to be developed. Our objective here was to propose such outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This proposal is the result of 4 face\u2010to\u2010face consensus meetings with a 27\u2010member multidisciplinary team of pediatric rheumatologists, adult rheumatologists, dermatologists, pediatric cardiologists, pulmonologists, gastroenterologists, a statistician, and patients. Throughout the process, we reviewed the existing adult data in this field, the more limited pediatric literature for juvenile SSc outcomes, and data from 2 juvenile SSc patient cohorts to assist in making informed, data\u2010driven decisions. The use of items for each domain as an outcome measure in an open label 12\u2010month clinical trial of juvenile SSc was voted and agreed upon using a nominal group technique.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>After voting, the domains agreed on were global disease activity, skin, Raynaud's phenomenon, digital ulcers, musculoskeletal, cardiac, pulmonary, renal, and gastrointestinal involvement, and quality of life. Fourteen outcome measures had 100% agreement, 1 item had 91% agreement, and 1 item had 86% agreement. The domains of biomarkers and growth\/development were moved to the research agenda.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We reached consensus on multiple domains and items that should be assessed in an open label, 12\u2010month clinical juvenile SSc trial as well as a research agenda for future development.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr.25171","type":"journal-article","created":{"date-parts":[[2023,6,18]],"date-time":"2023-06-18T22:24:26Z","timestamp":1687127066000},"page":"2453-2462","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Proposed Response Parameters for <scp>Twelve\u2010Month<\/scp> Drug Trial in Juvenile Systemic Sclerosis: Results of the Hamburg International Consensus Meetings"],"prefix":"10.1002","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0659-5298","authenticated-orcid":false,"given":"Ivan","family":"Foeldvari","sequence":"first","affiliation":[{"name":"Sch\u00f6n Klinik Hamburg Eilbek  Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1662-143X","authenticated-orcid":false,"given":"Kathryn S.","family":"Torok","sequence":"additional","affiliation":[{"name":"University of Pittsburgh and Children's Hospital of Pittsburgh  Pittsburgh Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8792-4219","authenticated-orcid":false,"given":"Jordi","family":"Anton","sequence":"additional","affiliation":[{"name":"Hospital Sant Joan de D\u00e9u and Universitat de Barcelona  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Blakley","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine and Riley Hospital for Children at IU Health  Indianapolis"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tam\u00e1s","family":"Constantin","sequence":"additional","affiliation":[{"name":"Semmelweis University  Budapest Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Curran","sequence":"additional","affiliation":[{"name":"University of Colorado School of Medicine and Children's Hospital Colorado  Aurora"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5396-0932","authenticated-orcid":false,"given":"Maurizio","family":"Cutolo","sequence":"additional","affiliation":[{"name":"University of Genoa and IRCCS San Martino Polyclinic Hospital  Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3975-8938","authenticated-orcid":false,"given":"Christopher","family":"Denton","sequence":"additional","affiliation":[{"name":"Royal Free London NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Fligelstone","sequence":"additional","affiliation":[{"name":"Scleroderma &amp; Raynaud's United Kingdom  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Ingegnoli","sequence":"additional","affiliation":[{"name":"University of Milan, ASST G. 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