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

Last updated: September 18, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT06603337
STRIKE - 6837
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

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 smallmolecule) therapy for IBD and who have experienced failure to at least one mechanismof action (failure is defined as primary failure, secondary failure, orintolerance).

  4. Patients who have already started a new advanced therapy for IBD based on clinicalpractice indication (primary loss of response, secondary loss of response,intolerance to the previous drug) since at least 1 week and up to 8 weeks afterstarting it.

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

Exclusion

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 subjectto participate to the study.

Study Design

Total Participants: 2700
Study Start date:
September 18, 2024
Estimated Completion Date:
October 01, 2028

Study Description

Multicenter, ambispectic observational study with drug

Connect with a study center

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

    Roma, 00168
    Italy

    Active - Recruiting

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