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The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease

NCT06785493 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2025-01-21

No results posted yet for this study

Summary

The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD).

Conditions

  • IBD (Inflammatory Bowel Disease)

Interventions

DRUG

Optimized Treatment (OPT)

After the first sufficient intravenous infusion of UST (6 mg/kg), the patient's response was assessed based on PRO2 at week 8, and an individualized treatment plan was developed. At week 8, the patients with incomplete response of PRO2 (a decline of PRO2 was less than 50% from baseline or still in moderate to severe active phase of PRO2) were given one or more UST intravenous re-induction (6 mg/kg) every 4 or 6 weeks.

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06785493 on ClinicalTrials.gov