Status:
RECRUITING
Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
IBD (Inflammatory Bowel Disease)
Eligibility:
All Genders
18-70 years
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...
Detailed Description
Multicenter, ambispectic observational study with drug
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Age \< 18 years.
- Patients with diagnosis of indeterminate colitis.
- Patients naive to advanced (biological or small molecule) therapy for IBD.
- Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.
Key Trial Info
Start Date :
September 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT06603337
Start Date
September 18 2024
End Date
October 1 2028
Last Update
September 19 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Roma, Italy, 00168