SIIT Based on UST CDMT in Patients With CD
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SIIT group
|
Biological: selective intensive induction therapy based on ustekinumab clinical decision-making tools
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
|
| No Intervention: Non-intensive induction therapy group
|
Outcome Measures
Primary Outcome Measures
- Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen [week 24]
Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SxithSunYetSen