Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Recognizing the limitations of relying solely on endoscopic evaluation, this study aims to comprehensively assess the week-44 deep remission status in CD patients undergoing ustekinumab (UST) therapy. By systematically investigating baseline clinical, serological, and sonographic parameters, this research seeks to identify key predictive factors for deep remission, thereby providing robust clinical evidence to guide proactive and personalized UST optimization strategies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group | Each patient received an initial full-dose intravenous infusion of UST (6 mg/kg). At week 8, the clinical response was assessed based on the HBI. The patients who did not achieve clinical response [defined as a decrease in HBI < 3 from baseline, or remaining in moderate-to-severe clinical activity (HBI ≥ 8)] continued to receive intravenous UST infusions. The others who achieved clinical response at week 8 were switched to subcutaneous injections of 90 mg UST, followed by maintenance therapy with subcutaneous 90 mg UST every 8 weeks. During the follow-up period from week 8 to week 44, the PRO2 score was applied to monitor patients' response status. The patients who developed secondary loss of response (defined as liquid stool frequency ≥ 4 times/day or abdominal pain score ≥ 2) were re-administered intravenous UST infusions. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| deep remission rate at 44 week | At week 44 of UST therapy, the clinical remission rate (HBI ≤ 4), mucosal healing rate (SES-CD ≤ 2 or absence of ulcers), and transmural healing rate (bowel wall thickness ≤ 3 mm, normalized blood flow signal, preserved bowel wall stratification, and absence of mesenteric fat hypertrophy), and deep remission rate (simultaneous achievement of clinical remission, mucosal healing, and transmural healing) were evaluated. | at 44 week |
Not provided
Not provided
Inclusion Criteria:
1: Diagnosed with moderate to severe Crohn's disease 2.UST monotherapy 3.Follow-up time ≥44 weeks
Exclusion Criteria:
Not provided
Not provided
Crohn's disease (CD) is a chronic, progressive, transmural inflammation that can involve various parts of the oral to anal digestive tract.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D007410 | Intestinal Diseases |