A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China

NCT06082986 | Completed

• 2 other identifiers: CR109344PCSIMMA0055
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Bio-naive participants are defined as the participants who previously have not received any biologics for Crohn's Disease (CD).The purpose of this retrospective study is to describe the endoscopic remission at week 24 among bio-naive participants with CD treated with ustekinumab in China.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Endoscopic Remission at Week 24

  Endoscopic remission: simple endoscopic score for crohn's disease (SES-CD) less than or equal to (\<=) 2, total SES-CD \<=4, a decrease in total SES-CD greater than or equal to (\>=) 2 from baseline, and no subtotal SES-CD \>1 for each endoscopic parameter (for isolated ileal, ileocolonic and isolated colonic CD), rutgeerts score \<=i1 (for post-operation CD). SES-CD: assesses disease severity based on 4 endoscopic parameters across 5 ileocolonic segments. Total SES-CD = 0 to 56,higher scores = more severe disease. Rutgeerts score: assess postoperative disease recurrence with no lesions (i0); \<=5 aphthous lesions (i1); \>5 aphthous ulcers with normal intervening mucosa/patchy areas of larger lesions/lesions confined to ileocolic anastomosis (i2); diffuse aphthous ileitis and diffusely inflamed mucosa (i3); diffuse inflammation with large ulcers, nodules, and/or stenosis (i4).

  Week 24

Secondary Outcomes (19)

• Percentage of Participants With Endoscopic Response at Week 24

  Week 24

• Percentage of Participants With Clinical Remission at Week 24

  Week 24

• Percentage of Participants With Clinical Response at Week 24

  Week 24

• Percentage of Participants With Steroid-free Clinical Remission at Week 24

  Week 24

• Percentage of Participants With Steroid-free Clinical Response at Week 24

  Week 24

Study Arms (1)

Bio-naive Participants With Crohn's Disease (CD)

Participants with CD from inflammatory bowel disease (IBD) database who received ustekinumab from 20 May 2020 to 16 September 2022 in the real-world setting in China will be observed in the study. Only data available per routine clinical practice will be collected within this study.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

No interventions will be administered as a part of this study. Participants received ustekinumab as per their routine clinical practice.

Bio-naive Participants With Crohn's Disease (CD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of bio-naive participants who initiated ustekinumab therapy for the first time between 20 May 2020 and 16 September 2022.

You may qualify if:

• Participants with diagnosis of active Crohn's Disease (CD) (that is, Crohn's Disease Activity Index \[CDAI\] greater than or equal to \[\>=\] 150; Harvey-Bradshaw Index \[HBI\] \>=5; or determined by physicians)
• Participants with initiation of ustekinumab intravenous induction therapy for the first time between 20 May 2020 and 16 September 2022

You may not qualify if:

• Previously received ustekinumab for any indication other than CD
• Participants were previously exposed with any biologics (for example: adalimumab, infliximab, vedolizumab or their biosimilars) other than ustekinumab

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (3)

Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510000, China

Location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510000, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

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

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: October 9, 2023
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)