PROMPT-IBDNCT06758024

PROactive and Early Infliximab Monitoring and oPTimization in Inflammatory Bowel Disease

StatusRecruiting

PhaseNot applicable

SponsorPontificia Universidad Catolica de Chile

Primary completionMar 2027 (estimated)

At risk: Primary completion moved at least 1 year 1 month later.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 11, 2026 Primary completion pushed from Jan 2026 to Mar 2027 Show 4 more changesShow less
- Eligibility criteria expanded, about 8 words
- Study completion pushed from Jan 2027 to Jan 2028
- Secondary endpoints: details revised at 7 of 15 entries
- Study description expanded, about 2 words
Notable Feb 25, 2025 Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
- Start date changed from estimate of Jan 2025 to Jan 24, 2025
- Study description expanded, about 7 words
- Site details revised
- Collaborators revised (5)
Dec 26, 2024 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Infliximab optimal concentration

Timeframe: Week 14

Secondary (15)

Clinical remission

Corticosteroid-free clinical remission

Sustained corticosteroid-free clinical remission

CRP normalization

Fecal calprotectin normalization

Show 10 moreShow less

Primary non-response

Secondary loss of response

Antibodies to infliximab-free survival

Proportion of subjetcs with antibodies to infliximab

Time to antibodies to infliximab

Adverse events

Surgery

Time to surgery

Hospitalization

Time to hospitalization

Arms and interventions

Dashboad-guided dosingOther

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

Standard dosingOther

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

Drugs: Infliximab

Sites

1 site in 1 country

Pontificia Universidad Catolica of ChileSantiago, Chile

About this trial

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

Trial details

Enrollment: 72 participants (estimated)
Started: Jan 24, 2025
Study completion: Jan 2028 (estimated)
Eligibility: 18 to 75, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Oversight: No data monitoring committee
Conditions: Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC)
Collaborators: Clínica Universidad de los Andes, Hospital San Juan de Dios,Chile, University of Chile, Clinica Indisa, Universidad de La Frontera
Official title: Multicentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients
First posted: Jan 3, 2025
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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