Status:
RECRUITING
Effectiveness and Tolerance of IV vs SC Biological Drugs in Gastrointestinal Diseases
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
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 avai...
Detailed Description
The study is designed as a prospective, retrospective, 24-month observational cohort study. Patients' eligibility for enrolment will be assessed during the baseline visit at the Centre for Diseases of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06604728
Start Date
September 4 2023
End Date
September 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Roma, Italy, 00168