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SIIT Based on UST CDST in Patients With CD

Primary Purpose

Crohn Disease

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
selective intensive induction therapy based on ustekinumab clinical decision-making tools
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 with fibrous stenosis and prestenosis dilatation; Contraindications of UST as documented in other specifications.

Sites / Locations

  • SixthSunYetSenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SIIT group

Non-intensive induction therapy group

Arm Description

Outcomes

Primary Outcome Measures

Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen
Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen

Secondary Outcome Measures

Full Information

First Posted
May 6, 2023
Last Updated
July 21, 2023
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05861167
Brief Title
SIIT Based on UST CDST in Patients With CD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIIT group
Arm Type
Experimental
Arm Title
Non-intensive induction therapy group
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
selective intensive induction therapy based on ustekinumab clinical decision-making tools
Intervention Description
At week 0 and week 8, UST was induced intravenously twice (stratified according to body weight, see instructions for dosage), and at the third time, intravenous or standard subcutaneous injection regimen was used according to CRP standard
Primary Outcome Measure Information:
Title
Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen
Description
Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 with fibrous stenosis and prestenosis dilatation; Contraindications of UST as documented in other specifications.
Facility Information:
Facility Name
SixthSunYetSen
City
Guangzhou
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Hu
Phone
13535452363
Email
hujun33@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

SIIT Based on UST CDST in Patients With CD

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