Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".
Observational · No treatment assigned · 1 site · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 to 70
- Any sex
Some of the main requirements, copied from the record:
- Age 18 to 70 years
- Patients with a previous diagnosis of CD or UC at least 3 months before baseline.
- Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or…
Plus 2 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 2700 participants are expected to take part.
- Start date: 2024-09-18.
- Main results expected around 2026-10-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Steroid-free deep remission of IBD (24 months)
In the researchers’ words
Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively: * Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included. * Prospective cohort Consecutive patients with IBD who are starting, from clinical practice, new biological/small molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha,…
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 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Enrollment | 2700 (estimated) |
| Start date | 2024-09-18 |
| Primary completion (est.) | 2026-10-01 |
| First posted | 2024-09-19 |
| Last updated | 2024-09-19 |
| Official title | Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". A Key Multicenter Study |
| ClinicalTrials.gov ID | NCT06603337 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Age 18 to 70 years 2. Patients with a previous diagnosis of CD or UC at least 3 months before baseline. 3. Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or intolerance). 4. Patients who have already started a new advanced therapy for IBD based on clinical practice indication (primary loss of response, secondary loss of response, intolerance to the previous drug) since at least 1 week and up to 8 weeks after starting it. 5. Written informed consent certifying the willingness of the subject to participate to the study. Exclusion Criteria: 1. Age < 18 years. 2. Patients with diagnosis of indeterminate colitis. 3. Patients naive to advanced (biological or small molecule) therapy for IBD. 4. Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD | Roma | 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.