SIIT Based on UST CDST in Patients With CD

Last updated: July 21, 2023
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

selective intensive induction therapy based on ustekinumab clinical decision-making tools

Clinical Study ID

NCT05861167
2023ZSLYEC-353
  • Ages 18-75
  • All Genders

Study Summary

ustekinumab (UST) can effectively induce and maintain clinical remission and mucosal healing of Crohn's disease (CD), but some patients still have poor response. Dose optimization is an effective way to improve the response rate of UST, and re-intravenous induction is a common way of optimization. For patients with secondary loss of response, about half of the patients can re-respond after dose optimization. We plan to use CDST-UST to stratify the response level of patients before treatment, select patients with poor response, and initially give multiple intravenous therapy as an intensive induction therapy strategy, so as to improve the response rate of these patients and achieve individualized treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with CD;
  • Active period; Age 18-75 years old;
  • UST-CDST scores were used to treat patients with moderate and low responsive activity

Exclusion

Exclusion Criteria:

  • Subjects had undergone extensive colectomy, subtotal colectomy, or total colectomy;The subject currently has ileostomy and colostomy; Patients with significant liver,kidney, endocrine, respiratory, neurological or cardiovascular diseases; Patients withfibrous stenosis and prestenosis dilatation; Contraindications of UST as documented inother specifications.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: selective intensive induction therapy based on ustekinumab clinical decision-making tools
Phase: 4
Study Start date:
June 01, 2023
Estimated Completion Date:
June 01, 2024

Connect with a study center

  • SixthSunYetSen

    Guangzhou, 510655
    China

    Active - Recruiting

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