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Completed

NCT Number: NCT05642247

Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science

Crohn's disease(CD),a type of inflammatory bowel disease(IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. And Ustekinumab, a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23, is a newly targeted drug approved for the treatment of Crohn's disease in recent years.Based on the high-throughput imaging characteristic analysis technique, this study quantitatively analyzed the transmural inflammation of Crohn's disease, and discussed its prognostic value in the treatment of Ustekinumab, and further analyzed the increment of its relative clinical index.

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Key information

Conditions

Inflammatory Bowel Diseases Biologics Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inpatients with Crohn's disease diagnosed in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University from January 2020 to June 2022
  • Treated with Ustekinumab and followed up regularly for 20 weeks
  • Complete pre-treatment cross-sectional imaging data (CTE/MRE and US)

Exclusion criteria

  • The diagnosis is not clear
  • Under the age of 18
  • Lack of endoscopic and pathological data

Treatment and study plan

Primary outcomes

  1. endoscopic remission rate at 12 months

    Time frame: 12 months after first intervention administration

    endoscopic remission rate at 12 months

  2. normalization rate of serum biomarker at 12 months

    Time frame: 12 months after first intervention administration

    normalization rate of serum biomarker at 12 months

  3. clinical remission rate at 12 months

    Time frame: 12 months after first intervention administration

    clinical remission rate at 12 months

  4. clinical response rate at 12 months

    Time frame: 12 months after first intervention administration

    clinical response rate at 12 months

  5. endoscopic response rate at 12 months

    Time frame: 12 months after first intervention administration

    endoscopic response rate at 12 months

  6. life quality changes at 12 months

    Time frame: 12 months after first intervention administration

    life quality evaluated by CDAI (Crohn's Disease Activity Index) at 12 months

  7. endoscopic remission rate after induction therapy

    Time frame: 16 or 20 weeks after first intervention administration

    endoscopic remission rate after induction therapy

  8. normalization rate of serum biomarker after induction therapy

    Time frame: 16 or 20 weeks after first intervention administration

    normalization rate of serum biomarker after induction therapy

  9. clinical remission rate after induction therapy

    Time frame: 16 or 20 weeks after first intervention administration

    clinical remission rate after induction therapy

  10. clinical response rate after induction therapy

    Time frame: 16 or 20 weeks after first intervention administration

    clinical response rate after induction therapy

  11. endoscopic response rate after induction therapy

    Time frame: 16 or 20 weeks after first intervention administration

    endoscopic response rate after induction therapy

  12. life quality changes after induction therapy

    Time frame: 16 or 20 weeks after first intervention administration

    life quality evaluated by CDAI (Crohn's Disease Activity Index) after induction therapy

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 8, 2022
Registry last updated
Apr 29, 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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