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Efficacy and Safety of Selective Intensive Induction Therapy Based on Ustekinumab Clinical Decision-making Tools in Patients With Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study(SIIT-CD Study)
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
SixthSunYetSen
Guangzhou, 省/直辖市, China
Start Date
June 1, 2023
Primary Completion Date
June 1, 2024
Completion Date
June 1, 2024
Last Updated
July 24, 2023
140
ESTIMATED participants
selective intensive induction therapy based on ustekinumab clinical decision-making tools
BIOLOGICAL
Lead Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
NCT07245394
NCT07089420
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