{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T17:11:46Z","timestamp":1780333906784,"version":"3.54.1"},"reference-count":38,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2021,11,16]],"date-time":"2021-11-16T00:00:00Z","timestamp":1637020800000},"content-version":"unspecified","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["Pfizer Pharma GmbH, Germany"],"award-info":[{"award-number":["Pfizer Pharma GmbH, Germany"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,10,28]]},"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Psoriatic arthritis (PsA) is an inflammatory disease characterised by synovitis, enthesitis, dactylitis and axial involvement. The prevalence of axial involvement ranges from 25% to 70% in this patient group. Treatment recommendations for axial PsA were mainly extrapolated from guidelines for axial spondyloarthritis, and the main treatment options are non-steroidal anti-inflammatory drugs and biological disease-modifying antirheumatic drugs (tumour necrosis factor, IL-17 and IL-23 inhibitors). Tofacitinib was approved for the treatment of PsA and its efficacy on axial inflammation has been demonstrated in a phase II study of ankylosing spondylitis (AS). This prospective study aims to evaluate the efficacy of tofacitinib in reducing inflammation in the sacroiliac joints (SIJs) and spine on MRI in patients with axial disease of their PsA presenting with active axial involvement compatible with axial PsA.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analyses<\/jats:title>\n                  <jats:p>This is a randomised, double-blind, placebo-controlled, multicentre clinical trial in patients with axial PsA who have evidence of axial involvement, active disease as defined by a Bath AS Disease Activity Index score of \u22654 and active inflammation on MRI of the SIJs and\/or spine as assessed by and independent central reader. The study includes a 6-week screening period, a 24-week treatment period, which consist of a 12-week placebo-controlled double-blind treatment period followed by a 12-week active treatment period with tofacitinib for all participants, and a safety follow-up period of 4 weeks. At baseline, 80 subjects shall be randomised (1:1) to receive either tofacitinib or matching placebo for a 12-week double-blind treatment period. At week 12, an MRI of the whole spine and SIJs will be performed to evaluate the primary study endpoint.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The study will be performed according to the ethical principles of the Declaration of Helsinki and the German drug law. The independent ethics committees of each centre approved the ethical, scientific and medical appropriateness of the study before it was conducted.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04062695\">NCT04062695<\/jats:ext-link>; ClinicalTrials.gov and EudraCT No: 2018-004254-22; European Union Clinical Trials Register.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-048647","type":"journal-article","created":{"date-parts":[[2021,11,16]],"date-time":"2021-11-16T11:53:37Z","timestamp":1637063617000},"page":"e048647","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Efficacy of tofacitinib in reduction of inflammation detected on MRI in patients with Psoriatic ArthritiS presenTing with axial involvement (PASTOR): protocol of a randomised, double-blind, placebo-controlled, multicentre trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04062695","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4306-033X","authenticated-orcid":false,"given":"Fabian","family":"Proft","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universit\u00e4tsmedizin Berlin, Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murat","family":"Torgutalp","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universit\u00e4tsmedizin Berlin, Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Burkhard","family":"Muche","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universit\u00e4tsmedizin Berlin, Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valeria","family":"Rios Rodriguez","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universit\u00e4tsmedizin Berlin, Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryna","family":"Verba","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universit\u00e4tsmedizin Berlin, Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4537-6015","authenticated-orcid":false,"given":"Denis","family":"Poddubnyy","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universit\u00e4tsmedizin Berlin, Berlin, Berlin, Germany"},{"name":"Epidemiology Unit, German Rheumatism Research Centre, German Rheumatism Research Center Berlin, Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,11,16]]},"reference":[{"key":"2025101812455795000_11.11.e048647.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.08.042"},{"key":"2025101812455795000_11.11.e048647.2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2009.03565.x"},{"key":"2025101812455795000_11.11.e048647.3","doi-asserted-by":"publisher","DOI":"10.1002\/art.21972"},{"key":"2025101812455795000_11.11.e048647.4","first-page":"127","article-title":"Psoriatic arthritis (PSA)--an analysis of 220 patients","volume":"62","author":"Gladman","year":"1987","journal-title":"Q J Med"},{"key":"2025101812455795000_11.11.e048647.5","doi-asserted-by":"publisher","DOI":"10.1007\/s11926-007-0074-2"},{"key":"2025101812455795000_11.11.e048647.6","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209853"},{"key":"2025101812455795000_11.11.e048647.7","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1097\/BOR.0000000000000609","article-title":"Psoriatic spondylitis or ankylosing spondylitis with psoriasis: same or different?","volume":"31","author":"Chandran","year":"2019","journal-title":"Curr Opin Rheumatol"},{"key":"2025101812455795000_11.11.e048647.8","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.108217"},{"key":"2025101812455795000_11.11.e048647.9","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.108233"},{"key":"2025101812455795000_11.11.e048647.10","first-page":"S66","article-title":"Magnetic resonance imaging for diagnosing, monitoring and prognostication in psoriatic arthritis","volume":"33","author":"Poggenborg","year":"2015","journal-title":"Clin Exp Rheumatol"},{"key":"2025101812455795000_11.11.e048647.11","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1093\/rheumatology\/kez629","article-title":"Axial disease in psoriatic arthritis","volume":"59","author":"Helliwell","year":"2020","journal-title":"Rheumatology"},{"key":"2025101812455795000_11.11.e048647.12","doi-asserted-by":"crossref","first-page":"363","DOI":"10.1038\/s41584-018-0006-8","article-title":"Axial disease in psoriatic arthritis and ankylosing spondylitis: a critical comparison","volume":"14","author":"Feld","year":"2018","journal-title":"Nat Rev Rheumatol"},{"key":"2025101812455795000_11.11.e048647.13","doi-asserted-by":"crossref","first-page":"700.1","DOI":"10.1136\/annrheumdis-2020-217159","article-title":"EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update","volume":"79","author":"Gossec","year":"2020","journal-title":"Ann Rheum Dis"},{"key":"2025101812455795000_11.11.e048647.14","first-page":"n\/a","article-title":"Group for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendations for psoriatic arthritis","volume":"54","author":"Coates","year":"2016","journal-title":"Arthritis Rheumatol"},{"key":"2025101812455795000_11.11.e048647.15","doi-asserted-by":"crossref","first-page":"1340","DOI":"10.1093\/rheumatology\/kez457","article-title":"Is axial psoriatic arthritis distinct from ankylosing spondylitis with and without concomitant psoriasis?","volume":"59","author":"Feld","year":"2020","journal-title":"Rheumatology"},{"key":"2025101812455795000_11.11.e048647.16","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.190121"},{"key":"2025101812455795000_11.11.e048647.17","doi-asserted-by":"crossref","first-page":"1599","DOI":"10.1002\/art.41042","article-title":"2019 update of the American College of Rheumatology\/Spondylitis association of America\/Spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and Nonradiographic axial spondyloarthritis","volume":"71","author":"Ward","year":"2019","journal-title":"Arthritis Rheumatol"},{"key":"2025101812455795000_11.11.e048647.18","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210770"},{"key":"2025101812455795000_11.11.e048647.19","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-eular.2932"},{"key":"2025101812455795000_11.11.e048647.20","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1186\/s13075-018-1565-4","article-title":"Inflammatory back pain in psoriatic arthritis is significantly more responsive to corticosteroids compared to back pain in ankylosing spondylitis: a prospective, open-labelled, controlled pilot study","volume":"20","author":"Haroon","year":"2018","journal-title":"Arthritis Res Ther"},{"key":"2025101812455795000_11.11.e048647.21","doi-asserted-by":"publisher","DOI":"10.1039\/b606246f"},{"key":"2025101812455795000_11.11.e048647.22","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1615975"},{"key":"2025101812455795000_11.11.e048647.23","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1615977"},{"key":"2025101812455795000_11.11.e048647.24","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32483-8"},{"key":"2025101812455795000_11.11.e048647.25","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-eular.1082"},{"key":"2025101812455795000_11.11.e048647.26","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-eular.1229"},{"key":"2025101812455795000_11.11.e048647.27","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210322"},{"key":"2025101812455795000_11.11.e048647.28","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32463-2"},{"key":"2025101812455795000_11.11.e048647.29","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)32534-6"},{"key":"2025101812455795000_11.11.e048647.30","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.110767"},{"key":"2025101812455795000_11.11.e048647.31","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208642"},{"key":"2025101812455795000_11.11.e048647.32","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-eular.5510"},{"key":"2025101812455795000_11.11.e048647.33","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2011.150680"},{"key":"2025101812455795000_11.11.e048647.34","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2025101812455795000_11.11.e048647.35","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-201545"},{"key":"2025101812455795000_11.11.e048647.36","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.139667"},{"key":"2025101812455795000_11.11.e048647.37","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.147033"},{"key":"2025101812455795000_11.11.e048647.38","doi-asserted-by":"crossref","first-page":"418","DOI":"10.1002\/art.39434","article-title":"Course of magnetic resonance Imaging-Detected inflammation and structural lesions in the Sacroiliac joints of patients in the randomized, double-blind, placebo-controlled Danish multicenter study of adalimumab in spondyloarthritis, as assessed by the Berlin and spondyloarthritis research Consortium of Canada methods","volume":"68","author":"Pedersen","year":"2016","journal-title":"Arthritis Rheumatol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-048647","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T19:46:06Z","timestamp":1760816766000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-048647"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11]]},"references-count":38,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2021,11,16]]},"published-print":{"date-parts":[[2021,11]]}},"alternative-id":["10.1136\/bmjopen-2021-048647"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-048647","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11]]}}}