Actively Recruiting

Age: 18Years +
All Genders
NCT06604728

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-19

400

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 18 years
  • Confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis)
  • Receiving intravenous therapy with vedolizumab or infliximab; OR
  • Started subcutaneous vedolizumab or infliximab therapy at least 2 to 8 weeks after intravenous therapy for prospective cohort, or on subcutaneous therapy for more than 8 weeks after intravenous therapy for retrospective cohort
  • Stable steroid-free IBD clinical remission for at least 12 weeks, defined as Harvey Bradshaw Index < 5 or Partial Mayo Score < 2 at time of switching
  • Able to sign informed consent and comply with scheduled visits
Not Eligible

You will not qualify if you...

  • Dietary or medication changes during study period (prospective) or within 48 weeks after switching from intravenous to subcutaneous therapy (retrospective)
  • Patients with colectomy or cutaneous ostomy
  • Scheduled hospitalization or surgery during study participation
  • Enrolled in other interventional experimental protocols
  • Unstable personality or unable to follow protocol procedures
  • Any clinical condition deemed by investigators to contraindicate study enrollment
  • Refusal to sign informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, Italy, 00168

Actively Recruiting

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Research Team

F

Franco Scaldaferri, PI

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

1

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