Actively Recruiting
Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-19
2700
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Diagnosis of Crohn's disease or ulcerative colitis at least 3 months before baseline
- Previous failure of at least one advanced biological or small molecule therapy for IBD
- Started a new advanced IBD therapy between 1 week and 8 weeks before enrollment
- Willingness to provide written informed consent to participate in the study
You will not qualify if you...
- Age under 18 years
- Diagnosis of indeterminate colitis
- No prior treatment with advanced biological or small molecule therapy for IBD
- Refusal to sign written informed consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Roma, Italy, 00168
Actively Recruiting
Research Team
F
Franco Scaldaferri, PI
CONTACT
F
Francesca Profeta, SC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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