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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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 intolerance).

• 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.

• Written informed consent certifying the willingness of the subject to participate to the study.

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
RECRUITING
Roma
Contact Information
Primary
Franco Scaldaferri, PI
franco.scaldaferri@policlinicogemelli.it
+390630156876
Backup
Francesca Profeta, SC
francesca.profeta@guest.policlinicogemelli.it
+390630156876
Time Frame
Start Date: 2024-09-18
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 2700
Treatments
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 biologic/small molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha, multiple molecules are allowed), and who belong to the Lazio Regional Health System will be enrolled.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov