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

NCT06603337 | Recruiting

• 1 other identifier: STRIKE - 6837
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 1

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 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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with IBD, both UC and CD, who meet the inclusion and exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Franco Scaldaferri

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Scaldaferri, PI

CONTACT

+390630156876; franco.scaldaferri@policlinicogemelli.it

Francesca Profeta, SC

CONTACT

+390630156876; francesca.profeta@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)