{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T22:33:41Z","timestamp":1781735621129,"version":"3.54.5"},"reference-count":28,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2017,3,22]],"date-time":"2017-03-22T00:00:00Z","timestamp":1490140800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2017,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess efficacy and safety of fosdagrocorat (<jats:styled-content style=\"fixed-case\">PF<\/jats:styled-content>\u201004171327), a potential dissociated agonist of the glucocorticoid receptor, in rheumatoid arthritis (<jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content>) patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, double\u2010blind, parallel\u2010group, active\u2010 and placebo\u2010controlled Phase 2 study (<jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00938587) randomized 86 patients (1 : 1 : 1 : 1) to receive fosdagrocorat 10 mg, fosdagrocorat 25 mg, prednisone 5 mg or placebo, all with stable background methotrexate therapy. The primary outcome was change from baseline in Disease Activity Score of 28 joints (<jats:styled-content style=\"fixed-case\">DAS<\/jats:styled-content>28\u20104[C\u2010reactive protein (<jats:styled-content style=\"fixed-case\">CRP<\/jats:styled-content>)]) after 2 weeks of treatment. Secondary outcomes included American College of Rheumatology (<jats:styled-content style=\"fixed-case\">ACR<\/jats:styled-content>) response rates, change from baseline in <jats:styled-content style=\"fixed-case\">ACR<\/jats:styled-content> core components and Health Assessment Questionnaire Disability Index.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At week 2, improvements from baseline in <jats:styled-content style=\"fixed-case\">DAS<\/jats:styled-content>28\u20104(<jats:styled-content style=\"fixed-case\">CRP<\/jats:styled-content>) with fosdagrocorat 10 and 25 mg, prednisone 5 mg and placebo were \u22121.69, \u22122.22, \u22121.17 and \u22120.96, respectively, and were statistically significantly greater for both fosdagrocorat doses versus placebo (<jats:italic>P<\/jats:italic> &lt; 0.05) and for fosdagrocorat 25 mg versus prednisone 5 mg (<jats:italic>P<\/jats:italic> &lt; 0.001). The effects of fosdagrocorat on secondary outcomes were generally consistent with those observed for the primary outcome. Adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) were reported for eight (38%), three (14%), four (19%) and 12 (55%) patients treated with fosdagrocorat 10 and 25 mg, prednisone 5 mg and placebo, respectively. Most <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were mild in severity. Four patients discontinued treatment due to <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (fosdagrocorat 10 mg, <jats:italic>n<\/jats:italic> = 2; placebo, <jats:italic>n<\/jats:italic> = 2). There were no serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Fosdagrocorat 10 and 25 mg demonstrated efficacy in improving signs and symptoms in <jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content> patients, with manageable <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s. Additional studies are needed to assess the longer\u2010term safety and efficacy of fosdagrocorat.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.13053","type":"journal-article","created":{"date-parts":[[2017,3,23]],"date-time":"2017-03-23T07:41:18Z","timestamp":1490254878000},"page":"960-970","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Improved disease activity with fosdagrocorat (<scp>PF<\/scp>\u201004171327), a partial agonist of the glucocorticoid receptor, in patients with rheumatoid arthritis: a Phase 2 randomized study"],"prefix":"10.1111","volume":"20","author":[{"given":"Thomas","family":"Stock","sequence":"first","affiliation":[{"name":"Pfizer Inc Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dona","family":"Fleishaker","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Wang","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnab","family":"Mukherjee","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Mebus","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,3,22]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0b013e3282f51031"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0b013e32805e87d0"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.coph.2010.02.001"},{"key":"e_1_2_9_5_1","first-page":"696","article-title":"Corticosteroid use in rheumatoid arthritis: prevalence, predictors, correlates, and outcomes","volume":"34","author":"Caplan L","year":"2007","journal-title":"J Rheumatol"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204588"},{"key":"e_1_2_9_7_1","first-page":"CD001158","article-title":"Moderate\u2010term, low\u2010dose corticosteroids for rheumatoid arthritis","author":"Criswell LA","year":"2000","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0b013e3280d6471a"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kes086"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bone.2003.11.026"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.4088\/PCC.v03n0104"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/00004714-200202000-00009"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajpendo.1996.271.2.E317"},{"key":"e_1_2_9_14_1","first-page":"503","article-title":"Dissociated glucocorticoid receptor ligands: compounds with an improved therapeutic index","volume":"6","author":"Sch\u00e4cke H","year":"2005","journal-title":"Curr Opin Investig Drugs"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.2174\/156802608783955737"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0035155"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm4019178"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1210\/en.2010-1447"},{"key":"e_1_2_9_19_1","unstructured":"ZutshiA LongK MeltonMet al. 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