Crohn Disease and Ulcerative ColitisIBDMonitorNCT06666569
Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL in Patients With IBD
An observational study of Crohn Disease and Ulcerative Colitis, run by Hospital de Basurto at 1 site in Spain.
Trial summary
To establish the efficacy, safety, effectiveness and efficiency of monitoring the levels of anti-TNFα drugs and the levels of antibodies generated against these drugs in the treatment of patients with moderate or severe IBD (CD/CU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease and Ulcerative Colitis
- What is being tested?
- Use of the test for treatment optimization
- Type of treatment
- Medical device
- How many people
- 209 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2017to 8 May 2023
- How long will I take part?
- 32 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) on treatment with Infliximab or Adalimumab and who have been clinically stable for 12 weeks.
Who may be able to join
- patients of both sexes
- over 18 years of age
- diagnosis of CD/CU confirmed by endoscopy
- stable clinical status (remission) for at least 12 weeks prior to inclusion in the study
- on treatment with IFX/ADL for at least 3 months with stabilized dosage and outside the induction period
- negative for tuberculosis at the start of treatment
- who sign the informed consent form
Who cannot join
- severe concomitant pathology preventing adequate follow-up of patients.
- continued corticosteroid therapy at prednisone equivalent doses higher than 40 mg/day
- patients with positive antibody levels at baseline
- there is treatment with immunomodulators and/or corticoids, when it is at high doses and with variations in time
- Patients with intestinal resection and Crohn's disease in prophylactic treatment with anti-TNF, but without recurrence.
- who are participating in a clinical trial or interventional study. Participation in the study will be offered to all patients who meet the above criteria, and in a consecutive manner, without a prior selection process. The comparison group will consist of a cohort of patients belonging to the same Digestive Services and meeting the same selection criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL to Assist in Taking Clinical Decisions in Patients With IBD Treated With IFX or ADA
To establish the efficacy, safety, effectiveness and efficiency of monitoring the levels of anti-TNFα drugs and the levels of antibodies generated against these drugs in the treatment of patients with moderate or severe IBD (CD/CU).
An analysis will be made of the economic impact on the Health System of monitoring treatment with anti-TNFα drugs in CD/CU.
As a result of this specific objective, a standardized procedure will be established for the evaluation of the response to treatment with anti-TNFα drugs for CD/CU that includes the new trials and the new devices developed.
Read the detailed description
- To evaluate whether a dose and plasma level optimization strategy based on the use of Promonitor-IFX, Promonitor-Anti-IFX, Promonitor-ADL, and Promonitor-Anti-ADL kits in CD/CU patients on IFX/ADL treatment is superior in terms of the percentage of patients in clinical remission at 12 months compared to standard practice.
- To evaluate whether a dose and plasma level optimization strategy based on the use of Promonitor-IFX, Promonitor-Anti-IFX, Promonitor-ADL, and Promonitor-Anti-ADL kits in CD/CU patients on IFX/ADL treatment is superior in terms of the percentage of patients in deep remission at 12 months compared to standard practice.
- To analyze the influence of the use of the IFX/ADL antibody detection test in moderate to severe CD/CU patients on the annual direct cost to the health system of these patients, compared to the non-use of the tests.
- To evaluate the effectiveness of IFX/ADL antibody testing in moderate to severe CD/CU patients on the increase in quality-adjusted life-years compared to non-use of the tests.
- To evaluate the effectiveness of testing for antibodies to IFX/ADL in moderate to severe CD/CU patients in reducing the number of flares, compared to not using the tests.
Exploratory objective - To conduct a cost-effectiveness (utility) analysis of a strategy for the management of stable moderate to severe CD/CU patients based on treatment monitoring.
Page 10 of 83 anti-TNFα with the introduction of screening tests for plasma levels/antibodies to IFX/ADL with respect to standard practice based on clinical signs/symptoms.
Main operational objective
- To assess whether the prevalence of 1-year remission in moderate to severe CD/CU patients whose anti-TNFα treatment has been managed using Promonitor IFX/ADL kits is at least 16% higher compared to the group of patients in whom this technique has not been employed.
- Conditions
- Crohn Disease and Ulcerative Colitis
- Being tested
- Use of the test for treatment optimization
- Keywords
- IBD, Anti-TNFα, Promonitor-IFX/ADL, Promonitor-Anti-IFX/ADL
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the test for treatment optimizationDevice
Intervention cohort, where the clinician will have information on the test results to support decision making on treatment optimization. The randomization process will be by blocks and weighted to the ADL/IFX ratio of use of these treatments in the usual clinical practice of the participating hospitals, to guarantee a homogeneous distribution of the treatments in the groups at the beginning/end of the follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Cohort and Clinical Practice Cohort | Cohort of routine practice, where the clinician will be blinded to these results.
The randomization process will be by blocks and weighted to the ADL/IFX ratio of use of these treatments in the usual clinical practice of the participating hospitals, to guarantee a homogeneous distribution of the treatments in the groups at the beginning/end of the follow-up. Receives: Device: Use of the test for treatment optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacological management of IBD
Follow-up of two cohorts made up of patients diagnosed with moderate severe CD/UC, from the Basurto University Hospital, Cruces University Hospital and San Eloy Hospital, and who are being treated with IFX/ADL, and stable in terms of disease activity
Measured: 32 meses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start16 Jan 2017
- Primary completion3 Oct 2019
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease and Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
- Target duration
- 32 Months
Sponsor and investigators
- Lead sponsor
- Hospital de Basurto
- Sponsor type
- University, hospital or other
- Collaborators
- PROGENIKA BIOPHARMA, A GRIFOLS Company
- Responsible party
- Principal investigator, Maria del Carmen Muñoz Villafranca, Hospital de Basurto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666569
- Sponsor's protocol ID
- IBD-MONITOR
- Acronym
- IBDMonitor
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL to Assist in Taking Clinical Decisions in Patients With IBD Treated With IFX or ADA
- ClinicalTrials.gov ID
- NCT06666569
- Acronym / sponsor ID
- IBDMonitor / IBD-MONITOR
- Conditions
- Crohn Disease and Ulcerative Colitis
- Keywords
- IBD, Anti-TNFα, Promonitor-IFX/ADL, Promonitor-Anti-IFX/ADL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Hospital de BasurtoUniversity, hospital or other
- Collaborators
- PROGENIKA BIOPHARMA, A GRIFOLS Company
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 30 Oct 2024 (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.
To establish the efficacy, safety, effectiveness and efficiency of monitoring the levels of anti-TNFα drugs and the levels of antibodies generated against these drugs in the treatment of patients with moderate or severe IBD (CD/CU).
An analysis will be made of the economic impact on the Health System of monitoring treatment with anti-TNFα drugs in CD/CU.
As a result of this specific objective, a standardized procedure will be established for the evaluation of the response to treatment with anti-TNFα drugs for CD/CU that includes the new trials and the new devices developed.
Detailed description
- To evaluate whether a dose and plasma level optimization strategy based on the use of Promonitor-IFX, Promonitor-Anti-IFX, Promonitor-ADL, and Promonitor-Anti-ADL kits in CD/CU patients on IFX/ADL treatment is superior in terms of the percentage of patients in clinical remission at 12 months compared to standard practice.
- To evaluate whether a dose and plasma level optimization strategy based on the use of Promonitor-IFX, Promonitor-Anti-IFX, Promonitor-ADL, and Promonitor-Anti-ADL kits in CD/CU patients on IFX/ADL treatment is superior in terms of the percentage of patients in deep remission at 12 months compared to standard practice.
- To analyze the influence of the use of the IFX/ADL antibody detection test in moderate to severe CD/CU patients on the annual direct cost to the health system of these patients, compared to the non-use of the tests.
- To evaluate the effectiveness of IFX/ADL antibody testing in moderate to severe CD/CU patients on the increase in quality-adjusted life-years compared to non-use of the tests.
- To evaluate the effectiveness of testing for antibodies to IFX/ADL in moderate to severe CD/CU patients in reducing the number of flares, compared to not using the tests.
Exploratory objective - To conduct a cost-effectiveness (utility) analysis of a strategy for the management of stable moderate to severe CD/CU patients based on treatment monitoring.
Page 10 of 83 anti-TNFα with the introduction of screening tests for plasma levels/antibodies to IFX/ADL with respect to standard practice based on clinical signs/symptoms.
Main operational objective
- To assess whether the prevalence of 1-year remission in moderate to severe CD/CU patients whose anti-TNFα treatment has been managed using Promonitor IFX/ADL kits is at least 16% higher compared to the group of patients in whom this technique has not been employed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 32 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Cohort and Clinical Practice Cohort | – | Device: Use of the test for treatment optimizationCohort of routine practice, where the clinician will be blinded to these results. The randomization process will be by blocks and weighted to the ADL/IFX ratio of use of these treatments in the usual clinical practice of the participating hospitals, to guarantee a homogeneous distribution of the treatments in the groups at the beginning/end of the follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) on treatment with Infliximab or Adalimumab and who have been clinically stable for 12 weeks.
Key inclusion criteria (7 listed)
- patients of both sexes
- over 18 years of age
- diagnosis of CD/CU confirmed by endoscopy
- stable clinical status (remission) for at least 12 weeks prior to inclusion in the study
- on treatment with IFX/ADL for at least 3 months with stabilized dosage and outside the induction period
Key exclusion criteria (6 listed)
- severe concomitant pathology preventing adequate follow-up of patients.
- continued corticosteroid therapy at prednisone equivalent doses higher than 40 mg/day
- patients with positive antibody levels at baseline
- there is treatment with immunomodulators and/or corticoids, when it is at high doses and with variations in time
- Patients with intestinal resection and Crohn's disease in prophylactic treatment with anti-TNF, but without recurrence.
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 |
|---|---|---|
| Use of the test for treatment optimizationIntervention cohort, where the clinician will have information on the test results to support decision making on treatment optimization. The randomization process will be by blocks and weighted to the ADL/IFX ratio of use of these treatments in the usual clinical practice of the participating hospitals, to guarantee a homogeneous distribution of the treatments in the groups at the beginning/end of the follow-up. | Device | Intervention Cohort and Clinical Practice Cohort |
Primary outcome
Pharmacological management of IBD
Time frame: 32 meses
Follow-up of two cohorts made up of patients diagnosed with moderate severe CD/UC, from the Basurto University Hospital, Cruces University Hospital and San Eloy Hospital, and who are being treated with IFX/ADL, and stable in terms of disease activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Ulcerative Colitis, run by Hospital de Basurto at 1 site in Spain.
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 7 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: finished, as of the sponsor's last update on 30 Oct 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacological management of IBD (time frame: 32 meses). 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 30 Oct 2024.