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

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.

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Key information

Conditions

Crohn's Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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%

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: May 20, 2026
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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