MedTrace Logo

Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".

NCT06603337 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2700

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • IBD (Inflammatory Bowel Disease)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Franco Scaldaferri · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-18
Primary Completion
2026-10-01
Completion
2028-10-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06603337 on ClinicalTrials.gov