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RECRUITING
NCT06604728

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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 hospital admissions , improved pharmacokinetics and pharmacoeconomic benefits For these reasons, the consolidation of the clinical practice of switching biological drugs to subcutaneous administration in patients with IBD in clinical remission could be a good strategy in terms of therapeutic efficacy and tolerability. To date, intravenous and subcutaneous therapy for the biologics considered in the present study is considered equivalent both from a pharmacokinetic point of view ("bioequivalence" of the drug) and from a clinical point of view due to the available efficacy and safety data. The clinical choice of one or the other formulation generally takes into consideration the patient's concern, the subject's venous availability and the experience of the prescribing doctor. This protocol aims to collect the "real life" clinical experience and describe the clinical progress of the patients.

Official title: Evaluation of Effectiveness and Tolerance of Intravenous and Subcutaneous Biological Drugs in Gastrointestinal Diseases (BIOES)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2023-09-04

Completion Date

2025-09-01

Last Updated

2024-09-19

Healthy Volunteers

No

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, Italy