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The trial will investigate the efficacy and safety of nintedanib in patients with progressive myositis-associated interstitial lung disease (MA-ILD).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods\/Design<\/jats:title>\n                <jats:p>MINT is an exploratory, prospective randomised placebo-controlled trial. Eligible patients will have myositis and evidence of fibrosing ILD on high-resolution computed tomography (HRCT), be taking standard of care medications for myositis, and meet criteria for ILD progression within the prior 24\u00a0months based on decline in FVC, worsened fibrosis on HRCT, and\/or worsened dyspnoea. Patients will be randomised 1:1 to receive nintedanib 150\u00a0mg twice daily or placebo for 12\u00a0weeks then open-label nintedanib for 12\u00a0weeks. Patients will be enrolled at local sites and a decentralised site. Most study visits will be completed remotely using telemedicine or digital health technologies. The primary endpoint is the change in Living with Pulmonary Fibrosis (L-PF) questionnaire dyspnoea domain score at week 12. Other endpoints include changes in other L-PF questionnaire domains, lung function, imaging, and physical activity, and assessment of adverse events. Data collected using remote versus clinic enrolment, and using home versus clinic spirometry, will be compared.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>MINT is an innovative, hybrid trial that will evaluate the effects of nintedanib on symptoms, quality of life, and ILD progression in patients with progressive MA-ILD and provide valuable information on the utility of decentralised recruitment and remote data collection in clinical trials.\n<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Clinicaltrials.gov NCT05799755 (date of registration: 05\/04\/2023).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12890-024-03314-0","type":"journal-article","created":{"date-parts":[[2024,10,30]],"date-time":"2024-10-30T17:02:45Z","timestamp":1730307765000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Design of a randomised controlled hybrid trial of nintedanib in patients with progressive myositis-associated interstitial lung disease"],"prefix":"10.1186","volume":"24","author":[{"given":"Rohit","family":"Aggarwal","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chester V.","family":"Oddis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel I.","family":"Sullivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siamak","family":"Moghadam-Kia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Didem","family":"Saygin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J.","family":"Kass","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane C.","family":"Koontz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peide","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig S.","family":"Conoscenti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy L.","family":"Olson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the MINT investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,10,30]]},"reference":[{"issue":"12","key":"3314_CR1","doi-asserted-by":"publisher","first-page":"1955","DOI":"10.1136\/annrheumdis-2017-211468","volume":"76","author":"IE Lundberg","year":"2017","unstructured":"Lundberg IE, Tj\u00e4rnlund A, Bottai M, Werth VP, Pilkington C, Visser M, et al. 2017 European League Against Rheumatism\/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups. 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All participants will provide written informed consent prior to entering the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"RA reports grants from Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Mallinckrodt, Pfizer, Q32; consulting fees from ActiGraph, Alexion, ANI, Argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta Bio, Capella, Corbus, CSL Behring, EMD Serono, Galapagos, Horizon Therapeutics, I-Cell, Lilly, Janssen, Kezar, Kyverna, Mallinckrodt, Merck, Octapharma, Pfizer, Roivant, Sanofi, Teva. CVO reports grants from Abcuro, Alexion, Argenx, CSL Behring, EMD Serono and has served on advisory boards for Cabaletta and Pfizer and Data Safety and Monitoring Boards for the trial \u201cAutologous Stem Cell Transplantation with CD34-Selected Peripheral Blood Stem Cells in Patients with Treatment Resistant Systemic Sclerosis\u201d and for \u201cReducing Inflammation for Greater Health Trial: The RIGHT Study\u201d. DIS reports grants from Boehringer Ingelheim and the National Heart, Lung, and Blood Institute (NHLBI) and holds stock in Amgen, Lilly, Johnson & Johnson, Merck. SM-K, DS and DCK have nothing to disclose. DJK reports grants from Boehringer Ingelheim, the US Department of Defense, and the National Institutes of Health. PL and ALO are employees of Boehringer Ingelheim Pharmaceuticals, Inc. CSC was an employee of Boehringer Ingelheim Pharmaceuticals, Inc. when this study was designed and this manuscript was developed.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"544"}}