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

NCT06604728 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Franco Scaldaferri, PI · Fondazione Policlinico Gemelli, Rome

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2025-09-01
Completion
2025-09-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604728 on ClinicalTrials.gov