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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIIT group | Experimental |
| |
| Non-intensive induction therapy group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selective intensive induction therapy based on ustekinumab clinical decision-making tools | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SixthSunYetSen | Recruiting | Guangzhou | 省/直辖市 | 510655 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| D007410 | Intestinal Diseases |