Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604728
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Effectiveness and Tolerance of IV vs SC Biological Drugs in Gastrointestinal Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Effectiveness and Tolerance of Intravenous and Subcutaneous Biological Drugs in Gastrointestinal Diseases BIOES
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOES
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 patients concern the subjects 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
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 patients concern the subjects 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
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 the Digestive System CEMAD Agostino Gemelli University Polyclinic Foundation IRCCS Università Cattolica del Sacro Cuore Subjects meeting all inclusion criteria will be enrolled and all subjects meeting at least one exclusion criterion will be excluded
A cohort of patients suffering from IBD undergoing therapy with biological drugs already undergoing retrospective cohort or who will undergo prospective cohort for clinical practice reasons a switch from the intravenous formulation to the corresponding subcutaneous formulation in particular from intravenous vedolizumab or infliximab to subcutaneous vedolizumab or infliximab will be considered
A cohort of patients suffering from IBD undergoing therapy with biological drugs already undergoing retrospective cohort or who will undergo prospective cohort for clinical practice reasons a switch from the intravenous formulation to the corresponding subcutaneous formulation in particular from intravenous vedolizumab or infliximab to subcutaneous vedolizumab or infliximab will be considered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None