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

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

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.

Study Overview

• Status: Recruiting
• Conditions: IBD (Inflammatory Bowel Disease)

Detailed Description

Multicenter, ambispectic observational study with drug

• Study Type: Observational
• Enrollment (Estimated): 2700

Contacts and Locations

• Study Contact: Name: Franco Scaldaferri, PI; Phone Number: +390630156876; Email: franco.scaldaferri@policlinicogemelli.it
• Study Contact Backup: Name: Francesca Profeta, SC; Phone Number: +390630156876; Email: francesca.profeta@guest.policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
    • Contact: Franco Scaldaferri; Phone Number: +390630156876; Email: franco.scaldaferri@policlinicogemelli.it
    • Principal Investigator: Franco Scaldaferri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Franco Scaldaferri, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: STRIKE - 6837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No