SIIT Based on UST CDST in Patients With CD

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT05861167
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Jul 2023
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SIIT group
  • No Intervention: Non-intensive induction therapy group

Primary Outcome Measure

Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen [ Time Frame: week 24 ]

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