Assessment on the Deep Remission Rate and Its Influencing Factors of Individualized Ustekinumab Therapy in Patients With Crohn's Disease

May 14, 2026 updated by: Second Affiliated Hospital of Wenzhou Medical University
In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Recognizing the limitations of relying solely on endoscopic evaluation, this study aims to comprehensively assess the week-44 deep remission status in CD patients undergoing ustekinumab (UST) therapy. By systematically investigating baseline clinical, serological, and sonographic parameters, this research seeks to identify key predictive factors for deep remission, thereby providing robust clinical evidence to guide proactive and personalized UST optimization strategies.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Crohn's disease (CD) is a chronic, progressive, transmural inflammation that can involve various parts of the oral to anal digestive tract.

Description

Inclusion Criteria:

1: Diagnosed with moderate to severe Crohn's disease 2.UST monotherapy 3.Follow-up time ≥44 weeks

Exclusion Criteria:

  1. UST combined with glucocorticoids, immunosuppressants, other biological agents or small molecule drugs
  2. complicated with infectious diseases (active tuberculosis, septicemia, etc.), cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, malignant tumors
  3. combined with systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases
  4. pregnancy or lactation
  5. Clinical data missing > 30%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation group
Each patient received an initial full-dose intravenous infusion of UST (6 mg/kg). At week 8, the clinical response was assessed based on the HBI. The patients who did not achieve clinical response [defined as a decrease in HBI < 3 from baseline, or remaining in moderate-to-severe clinical activity (HBI ≥ 8)] continued to receive intravenous UST infusions. The others who achieved clinical response at week 8 were switched to subcutaneous injections of 90 mg UST, followed by maintenance therapy with subcutaneous 90 mg UST every 8 weeks. During the follow-up period from week 8 to week 44, the PRO2 score was applied to monitor patients' response status. The patients who developed secondary loss of response (defined as liquid stool frequency ≥ 4 times/day or abdominal pain score ≥ 2) were re-administered intravenous UST infusions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
deep remission rate at 44 week
Time Frame: at 44 week
At week 44 of UST therapy, the clinical remission rate (HBI ≤ 4), mucosal healing rate (SES-CD ≤ 2 or absence of ulcers), and transmural healing rate (bowel wall thickness ≤ 3 mm, normalized blood flow signal, preserved bowel wall stratification, and absence of mesenteric fat hypertrophy), and deep remission rate (simultaneous achievement of clinical remission, mucosal healing, and transmural healing) were evaluated.
at 44 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 20, 2026

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2026-01-210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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