NCT06604728 Effectiveness and Tolerance of IV vs SC Biological Drugs in Gastrointestinal Diseases
| NCT ID | NCT06604728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-09-04 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 to 8 weeks after intravenous therapy with the same drugs for the prospective cohort and patients on subcutaneous vedolizumab and infliximab therapy for more than 8 weeks after intravenous therapy with the same drugs for the retrospective cohort; * Stable (at least 12 weeks) steroid-free IBD clinical remission, defined as a finding of Harvey Bradshaw Index3 (HBI) scores \< 5 or Partial Mayo Score 4.5 (PMS) \< 2 for patients with Crohn's disease or colitis ulcerative, respectively, assessed at the time of switching the drug to subcutaneous administration; * Ability to sign informed consent for participation in the study and to comply with the schedule of scheduled visits. Exclusion Criteria: * Patients with dietary or medication changes during the study period (for the prospective group) or who experienced dietary or medication changes in the 48 weeks between drug switching from intravenous to subcutaneous administration (for the retrospective group only) ; * Patients undergoing colectomy or with cutaneous ostomy; * Patients scheduled for hospitalization or surgery within the period of study participation; * Concomitant enrollment in other interventional experimental protocols; * Unstable personality or unable to adhere to protocol procedures; * Any clinical condition which, in the opinion of the investigators, may contraindicate enrollment in the study; * Refusal to sign informed consent to participate in the study.
Contact & Investigator
Franco Scaldaferri, PI
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Gemelli, Rome
Frequently Asked Questions
Who can join the NCT06604728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06604728 currently recruiting?
Yes, NCT06604728 is actively recruiting participants. Contact the research team at franco.scaldaferri@policlinicogemelli.it for enrollment information.
Where is the NCT06604728 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06604728 clinical trial?
NCT06604728 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Franco Scaldaferri, PI at Fondazione Policlinico Gemelli, Rome. The trial plans to enroll 400 participants.