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ClinicalTrials.gov ID:<\/strong> NCT07235904 Official title: <\/strong>Efficacy of top-down therapy with mirikizumab compared to standard therapy with azathioprine in patients with newly diagnosed moderate to severe ulcerative colitis: The MIRACLE study is aimed at patients who have been newly diagnosed with moderate to severe ulcerative colitis within the last 12 months and who have not responded adequately to treatment with mesalazine and prednisolone alone.<\/p>\n The standard drug therapy for ulcerative colitis usually begins with mesalazine (\u00b1 cortisone) and, if the response is insufficient, is continued with azathioprine (\u00b1 cortisone). Only in the next therapy step are so-called biologics (biotechnologically produced protein active substances such as antibodies) such as mirikizumab used. <\/p>\n However, recent studies have shown that earlier treatment with mirikizumab, without prior therapy with azathioprine, may be more effective in the long term. There is also evidence that this may be associated with fewer side effects. <\/p>\n The aim of this study is to investigate whether direct, early treatment with mirikizumab is more effective than the usual start of standard therapy with azathioprine. Patients in the azathioprine group have the option of switching to mirikizumab from week 24 in the course of the study, provided that there is defined disease activity despite azathioprine therapy. <\/p>\n The study consists of:<\/p>\n Patients in the mirikizumab study arm receive a total of 12 doses of mirikizumab. The treatment is initially carried out with 300 mg intravenously every 4 weeks at the study center. Mirikizumab is then administered subcutaneously at a dose of 200 mg, consisting of two injections of 100 mg each, which are carried out independently at home. <\/p>\n Patients in the azathioprine study arm receive a daily dose of azathioprine tablets in combination with a corticosteroid.<\/p>\n Allocation to one of the two treatment arms is randomized, with each of the two therapy options being assigned with equal probability.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Efficacy of top-down therapy with mirikizumab compared to standard therapy with azathioprine in patients with newly diagnosed moderate to severe ulcerative colitis (MIRACLE) ClinicalTrials.gov ID: NCT07235904Sponsor: Universit\u00e4tsklinikum Schleswig-Holstein (Information provided by Universit\u00e4tsklinikum Schleswig-Holstein (responsible party)) Official title: Efficacy of top-down therapy with mirikizumab compared to standard therapy with azathioprine in patients with newly diagnosed moderate […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[40,36],"tags":[],"class_list":["post-464","post","type-post","status-publish","format-standard","hentry","category-active-searching","category-for-study-partners"],"yoast_head":"\n
Sponsor:<\/strong> Universit\u00e4tsklinikum Schleswig-Holstein (Information provided by Universit\u00e4tsklinikum Schleswig-Holstein (responsible party))<\/p>\n
a 52-week, multicenter, open-label, randomized controlled trial<\/p>\nStudy overview<\/h3>\n
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