Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease⦠(NCT03606499) | Clinical Trial Compass
CompletedNot Applicable
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
France111 participantsStarted 2018-09-26
Plain-language summary
The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's Disease \[CD\] and Ulcerative Colitis \[UC\]).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* With a confirmed diagnosis of CD or UC
* With at least one EIM of interest (cutaneous: pyoderma gangrenosum; erythema nodosum, articular: axial spondyloarthritis and peripheral spondyloarthritis with and without psoriasis, dactylitis, enthesitis; ocular: uveitis) and/or at least one IMIDs of interest (cutaneous: psoriasis, atopic dermatitis, hidradenitis suppurativa), suspected or confirmed, that is active at the time of screening
* Starting ustekinumab as a biologic therapy for CD or UC treatment independently of their enrollment into the study
* Using ustekinumab according to the SmPC
* Only for participants with CD: has had an inadequate response with or lost response to or be intolerant to conventional therapy including azathioprine, 6-mercaptopurine or corticosteroids or; at least one tumor necrosis factor (TNF) blocker (adalimumab, infliximab). Only for participants with UC: Have had an inadequate response with, lost response to, or were intolerant to either conventional including azathioprine, 6-mercaptopurine or corticosteroids or a biologic
Exclusion Criteria:
* Participants suffering from a psoriasis induced by a biological therapy at inclusion (including TNF blocker) or participant presenting an active psoriasis that was diagnosed before the time of inflammatory bowel disease (IBD) diagnosis
* Participants currently enrolled in an investigational study (or have been in the past 2 months) or are unwilling or not able to understand or provideā¦
What they're measuring
1
Percentage of Participants Achieving a Clinical Response (CR) on at Least one Extra-intestinal Manifestation/Immune-mediated Inflammatory Disease (EIM/IMID) Associated with Inflammatory Bowel Disease (IBD) at Week 24