Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL in Patients With IBD

Completed

• Conditions: Crohn Disease and Ulcerative Colitis

• Registration Number: NCT06666569
• Lead Sponsor: Hospital de Basurto

Brief 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).

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 Timeline

• Study Start: 2017-01-16
• Primary Completion: 2019-10-03
• Study Completion: 2023-05-08
• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacological management of IBD	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

Trial Locations

Locations (1)

Basurto University Hospital; 🇪🇸 Bilbao, Bizkaia, Spain