Optimizing Ustekinumab Treatment for Crohn's Disease
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）
This study is testing a new way to improve treatment for people with Crohn's disease by using a special tool to find those who need a stronger start with their ustekinumab therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | ustekinumab |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT05861167 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on improving the treatment response of patients with Crohn's disease (CD) who are receiving ustekinumab (UST). It employs a clinical decision-making tool to assess patient response levels before treatment and selects those with poor responses for an intensive induction therapy strategy. The goal is to enhance the effectiveness of UST through dose optimization and personalized treatment plans. By utilizing selective intensive induction therapy, the study aims to achieve better clinical outcomes for patients with moderate and low responsiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 diagnosed with active Crohn's disease and exhibiting moderate to low responsiveness to ustekinumab.
Not a fit: Patients who have undergone extensive bowel surgeries or have significant comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with Crohn's disease who struggle to respond to standard ustekinumab therapy.
How similar studies have performed: Other studies have shown promise in optimizing ustekinumab dosing strategies, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou
- SixthSunYetSen — Guangzhou, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.