PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease

NCT06758024 | Recruiting

• 2 other identifiers: 240320009SA24I0002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Inflammatory Bowel Disease (IBD); Crohn Disease (CD); Ulcerative Colitis (UC)

Keywords

Inflammatory Bowel Disease; Infliximab; dashboard-guided dosing; therapeutic drug monitoring

Outcome Measures

Primary Outcomes (1)

• Infliximab optimal concentration

  Proportion of patients who achieve infliximab trough levels between 7-20 mcg/ml at week 14 of treatment

  Week 14

Secondary Outcomes (15)

• Clinical remission

  Week 52

• Corticosteroid-free clinical remission

  Week 52

• Sustained corticosteroid-free clinical remission

  Week 52

• CRP normalization

  Week 52

• Fecal calprotectin normalization

  Week 52

Study Arms (2)

Dashboad-guided dosing

OTHER

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

Drug: Infliximab

Standard dosing

OTHER

Eligible patients will receive IFX standard dosing during induction based solely on clinical data

Drug: Infliximab

Interventions

Infliximab DRUG

IFX therapeutic drug monitoring before the second and third infusion and subsequent dashboard-guided dosing regimes suggested to attending gastroenterologists based on clinical and pharmacokinetics data

Dashboad-guided dosing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participant younger than 18 years
• Non-controlled infectious diseases
• Permanent ileostomy or Ileal pouch-anal anastomosis
• Pregnancy
• Patients do not consent to participate in study
• Patients unable to comply with protocol

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Clínica Universidad de los Andes: collaborator
• Hospital San Juan de Dios,Chile: collaborator
• University of Chile: collaborator
• Clinica Indisa: collaborator
• Universidad de La Frontera: collaborator

Study Sites (1)

Pontificia Universidad Catolica of Chile

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Cristian Hernández-Rocha Cristian Hernández-Rocha, MD

CONTACT

56-22-3543838; caherna4@uc.cl

Carolina Pavez Carolina Pavez, MD

CONTACT

56-22-3543838; cdpavez@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Open-label, Multicenter Study

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: January 24, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2024-12

Locations

CL (1)