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NCT07600255Completed

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

Source: ClinicalTrials.gov · Last updated 20 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
156 (actual)
First submitted
14 May 2026
Start date
1 Jan 2021
Primary completion date
1 Jan 2026
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
NCT number
NCT07600255

What you commit to

  • Study type: Observational
  • Participants enrolled: 156
  • From 1 Jan 2021 to the primary completion date, 1 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • UST combined with glucocorticoids, immunosuppressants, other biological agents or small molecule drugs

Other illness

  • 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

Other

  • pregnancy or lactation
  • Clinical data missing \> 30%

Who the study is looking for

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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.