Inflammatory Bowel Disease (IBD)PROMPT-IBDNCT06758024
PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease
A study testing Infliximab in people with Inflammatory Bowel Disease (IBD) and Crohn Disease (CD), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChile
- Study dates
- 24 Jan 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Catolica of Chile
Santiago
Maria Balcells E, MD, +56955048170, proyectos.didemuc@uc.cl
About this study
Official title: Multicentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients
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.
Read more
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
Read the detailed description
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic diseases that entail important morbidity and frequently require high-cost medications such as biologic therapies. Monoclonal antibodies against tumoral necrosis factor (anti-TNF) are effective and can modify the progressive course of IBD. In Chile, given the high cost of anti-TNF therapy, this medication is provided by a national program with universal coverage. Unfortunately, a significant proportion of IBD patients never respond (primary non-response, PNR) or experience loss of response (secondary loss of response, SLR) to anti-TNF within the first year of therapy and current evidence support that the complex pharmacokinetics of anti-TNF is involved in both scenarios. Additionally, low trough levels (TL) are associated with the development of antidrug antibodies (ADA) which reduce anti-TNF efficacy and can cause anaphylactic reactions. This is particularly relevant for intravenous infliximab (IFX) which is usually indicated in IBD patients with acute severe disease not responding to iv corticosteroids. Therefore, IFX is frequently dose escalated in patients based on clinical parameters that are thought to be related to drug clearance with conflicting evidence supporting this strategy. Several studies have demonstrated that IFX TL between 7-20 mcg/ml at week 14 of treatment is a strong and independent predictor of therapy response. Furthermore, IFX dashboard-guided dose optimization based on clinical and pharmacokinetic (PK) parameters using adaptive Bayesian modeling have demonstrated to be more precise that empirical adjustments based on the clinician intuition alone. Therefore, the goal of this study is to analyze whether early therapeutic drug monitoring (TDM) and dose adjustment based on a Bayesian model (iDOSE) in CD and UC patients initiating IFX, increases the proportion of patients with therapeutic levels (7-20 mcg/ml), reducing immunogenicity and consequently increasing the rate of disease remission. A prospective multicentric randomized clinical trial (RCT) of Chilean adult IBD inpatients starting IFX due to moderate-to-severe disease refractory to corticosteroids will be carried out. Patients will be randomized 1:1 to:
- - Dashboard-guided dosing arm. Patients will undergo proactive TDM during induction (TL at IFN 2 and 3) with dose adjustment based on iDOSE.
- - Standard dosing arm. Patients will receive dose adjustment based solely on clinical parameters.
Both groups will be followed-up after induction with clinical visits, TL and ADA at week 14 (INF 4), 26 and 52. Researchers expect that a higher proportion of patients in the dashboard-guided dosing arm will achieve therapeutic TL of IFX (7-20 mcg/ml) at week 14 of treatment (Primary outome). Secondary outcomes will include clinical and laboratory parameters related to therapy response at week 52 of treatment, proportion of patients experiencing PNR and SLR, patients developing ADA, as well as, adverse events, hospitalization and surgery
- Being tested
- Infliximab
- Keywords
- Inflammatory Bowel Disease, Infliximab, dashboard-guided dosing, therapeutic drug monitoring
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
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
InfliximabDrug
No IFX therapeutic drug monitoring before the second and third infusion and subsequent dosing regimes based on clinical data
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Infliximab |
| Standard dosing | Other | Eligible patients will receive IFX standard dosing during induction based solely on clinical data Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infliximab optimal concentration
Proportion of patients who achieve infliximab trough levels between 7-20 mcg/ml at week 14 of treatment
Measured: Week 14
Secondary outcomes (15)
Clinical remission
Proportion of subjects in clinical remission at week 52 (CDAI <150 for CD or partial Mayo score < 2 for UC).
Measured: Week 52
Corticosteroid-free clinical remission
Proportion of subjects in Corticosteroid (CS)-free clinical remission at week 52 (CDAI <150 for CD or partial Mayo score < 2 for UC and no use of CS within previous 6 months).
Measured: Week 52
Sustained corticosteroid-free clinical remission
Proportion of subjects with sustained CS-free clinical remission at week 52 (CDAI <150 for CD or partial Mayo score < 2 for UC and no CS use from week 14 through week 52).
Measured: Week 52
CRP normalization
Proportion of subjects with normalisation of C-reactive protein (CRP) at week 52 (decrease from ≥1 at baseline to <1 mg/dL).
Measured: Week 52
Fecal calprotectin normalization
Proportion of subjects with normalisation of fecal calprotectin at week 52 (decrease from >250μg/g at baseline to ≤250mcg/g).
Measured: Week 52
Primary non-response
Proportion of subjects who are primary non-responders (≤70-point decrease in CDAI score for CD or decrease in partial Mayo score of ≥2 points and ≥25% for UC from baseline) and at least one of: CRP ≥1mg/dL or FC >250μg/g; or need for rescue therapy prior to week 14).
Measured: Week 14
Secondary loss of response
Proportion of subjects exhibiting secondary loss of response (CDAI >220 or partial Mayo score >4 and at least one of: CRP ≥1mg/dL or FC >250μg/g; or need for rescue therapy) during maintenance.
Measured: Week 14 through 52
Antibodies to infliximab-free survival
Proportion of subjects with no antibodies to infliximab (ATI).
Measured: Week 2 through 52
Proportion of subjetcs with antibodies to infliximab
Proportion of subjects with antibodies to infliximab (ATI)
Measured: Week 2 through 52
Time to antibodies to infliximab
Time to antibodies to infliximab (ATI) development.
Measured: Week 2 through 52
Adverse events
Proportion of subjects with any treatment-related adverse event.
Measured: Week 0 through 52
Surgery
Proportion of subjects with CD or UC-related surgery
Measured: Week 0 through 52
Time to surgery
Time to CD or UC-related surgery
Measured: Week 0 through 52
Hospitalization
Proportion of subjects with CD or UC-related hospitalisation.
Measured: Week 0 through 52
Time to hospitalization
Time to CD or UC-related hospitalisation
Measured: Week 0 through 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start24 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Open-label, Multicenter Study
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica Universidad de los Andes, Hospital San Juan de Dios,Chile, University of Chile, Clinica Indisa, Universidad de La Frontera
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758024
- Sponsor's protocol ID
- 240320009
- Other IDs
- SA24I0002
- Acronym
- PROMPT-IBD
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT06758024
- Acronym / sponsor ID
- PROMPT-IBD / 240320009
- Keywords
- Inflammatory Bowel Disease, Infliximab, dashboard-guided dosing, therapeutic drug monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Clínica Universidad de los Andes, Hospital San Juan de Dios,Chile, University of Chile, Clinica Indisa, Universidad de La Frontera
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic diseases that entail important morbidity and frequently require high-cost medications such as biologic therapies. Monoclonal antibodies against tumoral necrosis factor (anti-TNF) are effective and can modify the progressive course of IBD. In Chile, given the high cost of anti-TNF therapy, this medication is provided by a national program with universal coverage. Unfortunately, a significant proportion of IBD patients never respond (primary non-response, PNR) or experience loss of response (secondary loss of response, SLR) to anti-TNF within the first year of therapy and current evidence support that the complex pharmacokinetics of anti-TNF is involved in both scenarios. Additionally, low trough levels (TL) are associated with the development of antidrug antibodies (ADA) which reduce anti-TNF efficacy and can cause anaphylactic reactions. This is particularly relevant for intravenous infliximab (IFX) which is usually indicated in IBD patients with acute severe disease not responding to iv corticosteroids. Therefore, IFX is frequently dose escalated in patients based on clinical parameters that are thought to be related to drug clearance with conflicting evidence supporting this strategy. Several studies have demonstrated that IFX TL between 7-20 mcg/ml at week 14 of treatment is a strong and independent predictor of therapy response. Furthermore, IFX dashboard-guided dose optimization based on clinical and pharmacokinetic (PK) parameters using adaptive Bayesian modeling have demonstrated to be more precise that empirical adjustments based on the clinician intuition alone. Therefore, the goal of this study is to analyze whether early therapeutic drug monitoring (TDM) and dose adjustment based on a Bayesian model (iDOSE) in CD and UC patients initiating IFX, increases the proportion of patients with therapeutic levels (7-20 mcg/ml), reducing immunogenicity and consequently increasing the rate of disease remission. A prospective multicentric randomized clinical trial (RCT) of Chilean adult IBD inpatients starting IFX due to moderate-to-severe disease refractory to corticosteroids will be carried out. Patients will be randomized 1:1 to:
- - Dashboard-guided dosing arm. Patients will undergo proactive TDM during induction (TL at IFN 2 and 3) with dose adjustment based on iDOSE.
- - Standard dosing arm. Patients will receive dose adjustment based solely on clinical parameters.
Both groups will be followed-up after induction with clinical visits, TL and ADA at week 14 (INF 4), 26 and 52. Researchers expect that a higher proportion of patients in the dashboard-guided dosing arm will achieve therapeutic TL of IFX (7-20 mcg/ml) at week 14 of treatment (Primary outome). Secondary outcomes will include clinical and laboratory parameters related to therapy response at week 52 of treatment, proportion of patients experiencing PNR and SLR, patients developing ADA, as well as, adverse events, hospitalization and surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-label, Multicenter Study
| Arm | Type | Receives |
|---|---|---|
| Dashboad-guided dosing | Other | Drug: InfliximabEligible 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 dosing | Other | Drug: InfliximabEligible patients will receive IFX standard dosing during induction based solely on clinical data |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabIFX 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 | Drug | Dashboad-guided dosing |
| InfliximabNo IFX therapeutic drug monitoring before the second and third infusion and subsequent dosing regimes based on clinical data | Drug | Standard dosing |
Primary outcome
Infliximab optimal concentration
Time frame: Week 14
Proportion of patients who achieve infliximab trough levels between 7-20 mcg/ml at week 14 of treatment
15 secondary outcomes
Clinical remission
Time frame: Week 52
Corticosteroid-free clinical remission
Time frame: Week 52
Sustained corticosteroid-free clinical remission
Time frame: Week 52
CRP normalization
Time frame: Week 52
Fecal calprotectin normalization
Time frame: Week 52
Primary non-response
Time frame: Week 14
Secondary loss of response
Time frame: Week 14 through 52
Antibodies to infliximab-free survival
Time frame: Week 2 through 52
Proportion of subjetcs with antibodies to infliximab
Time frame: Week 2 through 52
Time to antibodies to infliximab
Time frame: Week 2 through 52
Adverse events
Time frame: Week 0 through 52
Surgery
Time frame: Week 0 through 52
Time to surgery
Time frame: Week 0 through 52
Hospitalization
Time frame: Week 0 through 52
Time to hospitalization
Time frame: Week 0 through 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infliximab in people with Inflammatory Bowel Disease (IBD) and Crohn Disease (CD), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristian Hernández-Rocha Cristian Hernández-Rocha, MD (56-22-3543838, caherna4@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infliximab optimal concentration (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.