Multicentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Infliximab (IFX) is a Food and Drug administration (FDA)-appoved monoclonal antibody medication targeting tumor necrosis factor (TNF) widely used in inflammatory bowel disease (IBD) to treat intestinal inflammation and improve patient's symptoms. Intravenous (iv) IFX is effective to treat hospitalized IBD patients with moderate-to-severe flares who fail iv corticosteroids (CS). However, about one-third of IBD patients do not respond to this medications and a half will loss the response after an initial response. Researchers have shown that most of these phenomena occur due to low IFX concentrations sometimes accompanied by the development of anti-drug antiboides (ADA) againts IFX. Blood concentrations of IFX are widely variable among IBD patients despite receiving the same weight-based dose. Several patient factors including laboratory parameters and severity of intestinal inflammation influence the way an individual's body proccesses and eliminate this type of medications. Dashboard software systems can take into account patient characteristics and IFX concentrations to modelate and facilitate dosing of IFX. By using pharmacokinetics (PK) models specifically developed to facilitate IFX dosing, these softwares can provide and recommend multiple dosing regimes to help the clinicians to select the appropriate dose to achieve target and optimal IFX concentrations. The goal of this clinical trial is to learn if early measuring of IFX blood concentrations and dashboard-guided IFX dose adjustment in Chilean IBD patients starting IFX, increases the proportion of patients with optimal IFX levels and improves patient outcomes. Researchers will measure IFX concentrations before the second (week 2) and third dose (week 6) in a prospectively collected individual patient cohort and this information along with clinical data will be analyzed with a dashboard software system and multiple dosing regime options will be provide to the attending clinicians to facilitate the selection of the next IFX weight-based dose and interval of infusions. This group will be compared with IBD patients with standard of dosing where attending clinicians make the dosing decisions based on clinical parameters. The main goal is to analyze if IBD patients in the dashboard-guided dosing arm achieve a higher proportion of optimal IFX concentrations at week 14 of treatment, develop ADA less frequently and improve clinical outcomes compared with standard dosing group. Participants will be asked to: * Provide clinical data about their disease and other conditions * Provide blood samples at enrollment and before each IFX infusion (IFN) during one year * Maintain regular clinical assessments every 3 months for one year

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adult inpatients with Crohn's disease, ulcerative colitis or inflammatory bowel disease-unclassified.

• Moderate-to-severe flare who fail to iv steroids and require infliximab as per standard of care by treating gastroenterologist

Locations
Other Locations
Chile
Pontificia Universidad Catolica of Chile
RECRUITING
Santiago
Contact Information
Primary
Cristian Hernández-Rocha Cristian Hernández-Rocha, MD
caherna4@uc.cl
56-22-3543838
Backup
Carolina Pavez Carolina Pavez, MD
cdpavez@uc.cl
56-22-3543838
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2027-01
Participants
Target number of participants: 72
Treatments
Other: Dashboad-guided dosing
Eligible patients will receive IFX with proactive therapeutic drug monitoring during induction (week 2 and 6) and dashboard-guided dosing options will be suggested to their attending gastroenterologists
Other: Standard dosing
Eligible patients will receive IFX standard dosing during induction based solely on clinical data
Sponsors
Collaborators: Clínica Universidad de los Andes, Clinica Indisa, University of Chile, Universidad de La Frontera, Hospital San Juan de Dios,Chile
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov