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Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively:
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.
Multicenter, ambispectic observational study with drug
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Steroid-free deep remission of IBD | To evaluate the percentage of patients achieving the steroid-free deep remission of UC and CD after 12 months of different II line therapy (second sequential biological/advanced therapy). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with IBD, both UC and CD, who meet the inclusion and exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franco Scaldaferri, PI | Contact | +390630156876 | franco.scaldaferri@policlinicogemelli.it | |
| Francesca Profeta, SC | Contact | +390630156876 | francesca.profeta@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Franco Scaldaferri | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD | Recruiting | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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