Clinical trial NCT03606499: 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
Official title: Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Colitis, Ulcerative
Lead sponsor: Janssen Cilag S.A.S.
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be participants with a confirmed diagnosis of moderate to severe Crohn's Disease (CD) or Ulcerative Colitis (UC) with at least one extra-intestinal manifestation (EIM) or immune-mediated inflammatory disease (IMID) of interest and for which a treatment with ustekinumab is indicated according to the clinical practice and Summary of Product Characteristics (SmPC).

Brief 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 \[UC\]).


Eligibility criteria: 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 provide their consent

Primary outcomes:
measure: 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
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants with Change from Baseline in Clinical Response for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
timeFrame: Baseline, Week 16 and Week 24
measure: Percentage of Participants Achieving Remission for CD as Measured by HBI
timeFrame: Up to Week 24
measure: Change from Baseline in Partial Mayo Score
timeFrame: Baseline, Week 16 and Week 24
measure: Percentage of Participants Achieving Remission for UC as Measured by Partial Mayo Score (Score of <=2)
timeFrame: Up to Week 24
measure: Change from Baseline in the Presence of Extra Intestinal Manifestations (EIMS) or Immune-Mediated Inflammatory Diseases (IMIDs)
timeFrame: Baseline and Week 24
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Baseline, Weeks 16 and Week 24
measure: Short Inflammatory Bowel Disease Questionnaire Score (Short IBDQ)
timeFrame: Baseline, Weeks 16 and 24
measure: Functional Assessment of Chronic Illness Therapy Scale (FACIT)
timeFrame: Baseline, Weeks 16 and 24
measure: Inflammatory Bowel Disease-Disability Index (IBD-DI)
timeFrame: Baseline, Weeks 16 and 24
measure: Number of Participants with Adverse Events
timeFrame: Up to 37 weeks
measure: Number of IBD Related Medical Visits
timeFrame: Week 24
measure: Number of Days of IBD Related Hospitalization with Surgery
timeFrame: Week 24
measure: Number of Days of IBD Related Hospitalization Without Surgery
timeFrame: Week 24
measure: Number of IBD Related Emergency Visits
timeFrame: Week 24
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy - Hopital de Brabois
Study officials:
affiliation: Janssen Cilag S.A.S.
name: Janssen Cilag S.A.S., France Clinical Trial
role: STUDY_DIRECTOR
References: