Comparing IV and SC biological drugs for gastrointestinal diseases
Evaluation of Effectiveness and Tolerance of Intravenous and Subcutaneous Biological Drugs in Gastrointestinal Diseases (BIOES)
This study tests whether switching from intravenous to subcutaneous biological drugs helps people with Inflammatory Bowel Disease feel better and have fewer hospital visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | vedolizumab, infliximab, adalimumab, golimumab, ustekinumab |
| Locations | 1 site (Roma) |
| Trial ID | NCT06604728 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and tolerance of intravenous (IV) versus subcutaneous (SC) biological drugs in patients with Inflammatory Bowel Disease (IBD). It will involve a cohort of patients who are either currently receiving IV therapy or have recently switched to SC therapy. The study will assess the clinical outcomes and tolerability of these treatments over a 24-month period, focusing on patients in clinical remission. The goal is to determine if switching to SC administration can maintain therapeutic efficacy while improving patient convenience and reducing hospital visits.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of IBD who are stable and in clinical remission while receiving IV biological therapy.
Not a fit: Patients who are not in clinical remission or those who have not received IV therapy prior to switching to SC therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing treatment regimens for IBD patients, potentially enhancing their quality of life.
How similar studies have performed: Previous studies have shown promising results in the effectiveness of SC biological therapies, suggesting that this approach may be beneficial for IBD patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Franco Scaldaferri, PI — Fondazione Policlinico Gemelli, Rome
- Study coordinator: Franco Scaldaferri, PI
- Email: franco.scaldaferri@policlinicogemelli.it
- Phone: +393334975975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.