Individual Treatment of Ustekinumab in Perianal Fistulizing Crohn's Disease
Observational · No treatment assigned · 1 site · Second Affiliated Hospital of Wenzhou Medical University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. 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 65
- Any sex
Some of the main requirements, copied from the record:
- Clinical diagnosis of Perianal Fistulizing Crohn's Disease
- Receive ustekinumab therapy
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 119 participants are expected to take part.
- Start date: 2024-12-20 (planned).
- Main results expected around 2024-12-31 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- imaging remission rate of anal fistula (Treatment week 0 to 32)
In the researchers’ words
This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease.
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 | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | Second Affiliated Hospital of Wenzhou Medical University |
| Enrollment | 119 (estimated) |
| Start date | 2024-12-20 |
| Primary completion (est.) | 2024-12-31 |
| First posted | 2024-12-18 |
| Last updated | 2024-12-18 |
| Official title | Analysis for the Efficacy of Individual Treatment of Perianal Fistulizing Crohn's Disease With Ustekinumab |
| ClinicalTrials.gov ID | NCT06739278 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Clinical diagnosis of Perianal Fistulizing Crohn's Disease * Receive ustekinumab therapy Exclusion Criteria: * Ustekinumab combined with hormones, immunosuppressants, other biologics or small molecule drugs * Combined with other autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Graves disease, etc. * Combined with serious infectious diseases, such as active tuberculosis, EBV infection, cytomegalovirus infection, etc. * Combined with malignant tumor * Clinical data missing ≥30% or no follow-up
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou, Zhejiang | China |
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.