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

NCT03606499 | Completed

• 2 other identifiers: CR108498CNTO1275CRD4012
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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 \[UC\]).

Conditions

Crohn Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (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

  CR will be determined based on the measures collected by the investigators which will be assessed by the specialists based on these parameters: 2 points reduction in physician global assessment (PGA) score or PGA 0 or 1 (0= clear to 5=very severe) achieved for cutaneous disease, or resolution of lesions for Erythema nodosum (dermatology); decrease of 50 percent (%) of ankylosing spondylitis disease activity index (BASDAI) (1=no problem to 10=worst problem) for axial spondyloarthritis (SpA); disease activity score (DAS)28 (derived from 4 items with score \<2.6 \[disease remission\] and \>5.1 \[severe disease activity\]) of moderate and good response achieved in peripheral SpA plus 2 points reduction in PGA score or PGA 0 or 1 achieved in case of associated psoriasis; resolution of dactylitis, decrease of 50% of Leeds enthesitis index \[LEI-6\] score which ranges from 0 \[pain/tenderness absent\] to1 \[pain/tenderness present\] for enthesitis, (rheumatology); resolution of uveitis (ophthalmology).

  Week 24

Secondary Outcomes (14)

• Percentage of Participants with Change from Baseline in Clinical Response for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)

  Baseline, Week 16 and Week 24

• Percentage of Participants Achieving Remission for CD as Measured by HBI

  Up to Week 24

• Change from Baseline in Partial Mayo Score

  Baseline, Week 16 and Week 24

• Percentage of Participants Achieving Remission for UC as Measured by Partial Mayo Score (Score of <=2)

  Up to Week 24

• Change from Baseline in the Presence of Extra Intestinal Manifestations (EIMS) or Immune-Mediated Inflammatory Diseases (IMIDs)

  Baseline and Week 24

Study Arms (1)

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.

Drug: Ustekinumab

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.

Inflammatory Bowel Disease (IBD) Participants with EIMs and/or IMIDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Cilag S.A.S.: lead

Study Sites (1)

CHU de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Cilag S.A.S., France Clinical Trial

  Janssen Cilag S.A.S.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: September 26, 2018
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

FR (1)