IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study
Observational · No treatment assigned · 1 site · The Third Xiangya Hospital of Central South University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease, Guselkumab and Intestinal Ultrasound. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- Age ≥ 18 years and ≤ 80 years;
- Patients with newly diagnosed or relapsed moderate to severe Crohn's disease;
- Guselkumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound;
Plus 2 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2025-06-16.
- Main results expected around 2027-07-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Bowel wall thickness(BWT) (follow-up time of about 56weeks)
In the researchers’ words
Crohn's disease (CD) is a chronic non-specific intestinal inflammatory disease with incompletely clarified etiology, which can involve multiple organs and systems , and is prone to severe complications such as intestinal obstruction, perforation, and fistula.Currently, the main therapeutic drugs for CD include aminosalicylates, glucocorticoids, immunosuppressants, biological agents, etc. With the development of…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn's Disease; Guselkumab; Intestinal Ultrasound; Predictor |
| Lead sponsor | The Third Xiangya Hospital of Central South University |
| Enrollment | 50 (estimated) |
| Start date | 2025-06-16 |
| Primary completion (est.) | 2027-07-30 |
| First posted | 2025-06-24 |
| Last updated | 2025-06-24 |
| Official title | Intestinal Ultrasound Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study |
| ClinicalTrials.gov ID | NCT07034664 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: Age ≥ 18 years and ≤ 80 years; * Patients with newly diagnosed or relapsed moderate to severe Crohn's disease; * Guselkumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound; * No history of abdominal surgery; * Clearly understand, voluntarily participate in the study, and sign an informed consent form. Exclusion Criteria: * Contraindications to Guselkumab: allergy, active tuberculosis or other active infections, and comorbidities such as severe liver dysfunction; * Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia; * Hypersensitivity to the components of SonoVue contrast media.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha, Hunan | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.