Effectiveness and Tolerance of IV vs SC Biological Drugs in Gastrointestinal Diseases

Recruiting Observational Study
Inflammatory Bowel Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
400 (estimated)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Other
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About This Trial
Biologics are effective pharmacological treatments for Inflammatory Bowel Disease (IBD). To date, in the context of these pathologies, the formulations that can be administered subcutaneously are available for all the biological agents on the market (infliximab, adalimumab, golimumab, vedolizumab and ustekinumab) and can guarantee self-administration of the therapy at home with a reduction in hosp…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis) * Intravenous therapy with vedolizumab or infliximab; OR * Patients who for clinical reasons initiated subcutaneous vedolizumab or infliximab therapy at least 2 and up t…
Contacts

Franco Scaldaferri, PI

+393334975975

franco.scaldaferri@policlinicogemelli.it

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