NCT06603337 Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".
| NCT ID | NCT06603337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | IBD (Inflammatory Bowel Disease) |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,700 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,700 participants in total. It began in 2024-09-18 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, more than one molecule is allowed), and who belong to the Lazio Regional Health System. Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre (CEMAD) of the Foundation and to all the other IBD Units of all the centres specified in Annex 1. Based on the number of patients referred to the clinics, we estimate 112 patients per month, the time for recruitment is 24 months. Potential study participants will receive oral and written information about the study. Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP.
Eligibility Criteria
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.
Contact & Investigator
Franco Scaldaferri
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06603337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying IBD (Inflammatory Bowel Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06603337 currently recruiting?
Yes, NCT06603337 is actively recruiting participants. Contact the research team at franco.scaldaferri@policlinicogemelli.it for enrollment information.
Where is the NCT06603337 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06603337 clinical trial?
NCT06603337 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Franco Scaldaferri at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 2,700 participants.