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

Sponsor
Janssen Cilag S.A.S.
Study ID
NCT03606499
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    No study treatment will be administered as a part of this study. Participants who are initiating the treatment with ustekinumab, will be observed according to standard clinical practice.

Study Details

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 \[UC\]).

Key Dates

Start date
Sep 26, 2018
Status verified
Apr 2025
Primary completion
Mar 17, 2023
Completion
Mar 17, 2023

Study Design

Enrollment
111 participants (actual)

Arms

  • Arm: Inflammatory Bowel Disease (IBD) Participants with EIMs and/or IMIDs
    IBD (Crohn's Disease \[CD\] or Ulcerative Colitis \[UC\]) participants with suspected extra-intestinal manifestations (EIMs) and/or one or more immune-mediated inflammatory diseases (IMIDs) will be enrolled into the study to assess effectiveness of ustekinumab on EIMs and/or IMIDs associated with IBD (both CD and UC). Participants will receive ustekinumab at study entry (Week 0) as treatment for IBD according to standard clinical practice and will be followed up to 24 weeks (+/- 3 weeks). Only data available per clinical practice will be collected within this study.

Primary Outcome 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 [ Time Frame: Week 24 ]

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