Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Cohort Study
Observational · No treatment assigned · 1 site · IRCCS Azienda Ospedaliero-Universitaria di Bologna
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD - Inflammatory Bowel 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 and older
- Any sex
Some of the main requirements, copied from the record:
- Signed informed consent
- Male and female patients, aged ≥18 years
- Patients who began treatment with Ustekinumab according to the indications for marketing authorization, following clinical practice and the information contained in the product's technical data sheet, during the period from February 2019…
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 12 participants are expected to take part.
- Start date: 2021-07-18.
- Main results expected around 2024-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Overall persistence of patients with Crohn's Disease and Ulcerative Colitis who started Ustekinumab. (Baseline; through study completion, an average of 2 years)
In the researchers’ words
Monocentric observational retrospective/prospective pharmacological study. Clinical records of patients with Ulcerative Colitis and Crohn's Disease who started therapy with Ustekinumab between February 2019 and March 2021 at the IBD Unit will be reviewed.
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 | IBD - Inflammatory Bowel Disease |
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Enrollment | 12 (estimated) |
| Start date | 2021-07-18 |
| Primary completion (est.) | 2024-12-31 |
| First posted | 2025-01-31 |
| Last updated | 2025-01-31 |
| Official title | Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Monocentric, Observational, Retrospective/Prospective Cohort Study |
| ClinicalTrials.gov ID | NCT06802887 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Signed informed consent * Male and female patients, aged ≥18 years * Patients who began treatment with Ustekinumab according to the indications for marketing authorization, following clinical practice and the information contained in the product's technical data sheet, during the period from February 2019 to March 2021. Exclusion Criteria: * None
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna, Bologna | Italy | 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.