Observational study on therapies for Inflammatory Bowel Disease
Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". A Key Multicenter Study
This study is testing new treatments for people with Inflammatory Bowel Disease who haven't had success with previous therapies to see how well they work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2700 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06603337 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of new biological and small molecule therapies in patients with Inflammatory Bowel Disease (IBD), specifically those who have previously failed at least one advanced therapy. The study will include both retrospective and prospective cohorts, with participants recruited from the Lazio Regional Health System over a 24-month period. Eligible patients will be those aged 18 to 70 with a diagnosis of Crohn's Disease (CD) or Ulcerative Colitis (UC) who have started a new therapy within the last 8 weeks. Participants will provide informed consent and will be monitored for treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of CD or UC who have failed at least one advanced therapy.
Not a fit: Patients under 18 years old or those who are naive to advanced therapy for IBD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with IBD who have not responded to previous therapies.
How similar studies have performed: Other studies have shown success with similar observational approaches in evaluating treatment outcomes for IBD.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Franco Scaldaferri — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Franco Scaldaferri, PI
- Email: franco.scaldaferri@policlinicogemelli.it
- Phone: +390630156876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.