{"id":414,"date":"2019-07-11T10:26:44","date_gmt":"2019-07-11T09:26:44","guid":{"rendered":"https:\/\/sclerodermie.ca\/?page_id=414"},"modified":"2024-04-30T16:02:46","modified_gmt":"2024-04-30T20:02:46","slug":"patient-participation-in-research","status":"publish","type":"page","link":"https:\/\/sclerodermie.ca\/en\/research\/patient-participation-in-research\/","title":{"rendered":"Patient Participation in Research"},"content":{"rendered":"<h2><span style=\"font-size: 14pt;\">NOTICE TO HEALTHCARE PROFESSIONALS<\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><br \/>\n<\/span>A clinical trial in scleroderma is currently recruiting at the CHUM. (VITALISScE\u2122\u00a0Trial)<\/p>\n<p>Please read the details of this clinical trial (VITALISScE\u2122) being conducted in the province of Quebec by Dr Sabrina Hoa&#8217;s team at the CHUM.<\/p>\n<p><strong>Clinical trial summary<\/strong><\/p>\n<p><strong>The VITALISScE<sup>TM<\/sup> clinical trial<\/strong><br \/>\nA phase 2, randomized, placebo-controlled, double-blind, parallel-group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with progressive systemic sclerosis (diffuse cutaneous system sclerosis (dcSSc) and limited cutaneous systemic sclerosis (lcSSc).<\/p>\n<p><strong>Investigational Treatment<\/strong><br \/>\nThe investigational medication, BI 685509, is being developed as a possible treatment for systemic sclerosis by targeting the disease\u2019s underlying vasculopathy and fibrosis.<\/p>\n<p><strong>Study Objectives<\/strong><br \/>\nThe primary objective of the VITALISScE\u2122 study is to demonstrate superiority of BI 685509 taken 3 times per day over placebo based on the mean difference in annual rate of decline in forced vital capacity over 48 weeks.<\/p>\n<p>The key secondary objectives of the study are to demonstrate superiority of BI 685509 over placebo for absolute change from baseline in Modified Rodnan Skin Score at Week 48 in patients with dcSSc, proportion of responders in patients with dcSSc based on revised Composite Response Index in Systemic Sclerosis at Week 48, and for absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 48<br \/>\nAdditional objectives are to evaluate safety, pharmacokinetic, and exploratory biomarkers.<\/p>\n<p><strong>Main eligibility criteria<\/strong><br \/>\nPatients in the VITALISScE\u2122 study must be 18 years of age or older (legal age at time of Informed Consent) and:<br \/>\n\u2022 Are patients with Sc, irrespective of associated ILD<br \/>\n\u2022 Must have PROGRESSING disease with FIBROSIS and VASCULOPATHY<br \/>\nOther criteria may apply.<\/p>\n<p><strong>To learn more or refer a potential VITALISScE\u2122 study participant, please contact:<\/strong> <a href=\"mailto:uit.eligibilite.chum@ssss.gouv.qc.ca\" target=\"_blank\" rel=\"noopener\">uit.eligibilite.chum@ssss.gouv.qc.ca<\/a> or 514-890-8000 ext. 30737<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>NOTICE TO HEALTHCARE PROFESSIONALS A clinical trial in scleroderma is currently recruiting at the CHUM. (VITALISScE\u2122\u00a0Trial) Please read the details of this clinical trial (VITALISScE\u2122) being conducted in the province of Quebec by Dr Sabrina Hoa&#8217;s team at the CHUM. Clinical trial summary The VITALISScETM clinical trial A phase 2, randomized, placebo-controlled, double-blind, parallel-group, efficacy [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":26156,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"page-groupe-de-recherche.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-414","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/pages\/414","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/comments?post=414"}],"version-history":[{"count":15,"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/pages\/414\/revisions"}],"predecessor-version":[{"id":28323,"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/pages\/414\/revisions\/28323"}],"up":[{"embeddable":true,"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/pages\/26156"}],"wp:attachment":[{"href":"https:\/\/sclerodermie.ca\/en\/wp-json\/wp\/v2\/media?parent=414"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}