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Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". | Clinical Trials | Clareo Health

RECRUITING

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

Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". A Key Multicenter Study

NCT06603337•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Multicenter, ambispectic observational study with drug

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, Italy

Key Dates

Start Date

September 18, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2028

Last Updated

September 19, 2024

Enrollment

2,700

ESTIMATED participants

Conditions

IBD (Inflammatory Bowel Disease)

Contacts

Franco Scaldaferri, PI

CONTACT

+390630156876 franco.scaldaferri@policlinicogemelli.it

Francesca Profeta, SC

CONTACT

+390630156876 francesca.profeta@guest.policlinicogemelli.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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