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

NCT07600255 | Completed

• 1 other identifier: SAHoWMU-CR2026-01-210
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Diseases

Keywords

Crohn's Disease; Ustekinumab; individualized therapy; deep remission

Outcome Measures

Primary Outcomes (1)

• deep remission rate 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

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 20, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)