NCT06666569

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 209 (actual)
• Sponsor: Hospital de Basurto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease and Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Use of the test for treatment optimization	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.

Timeline

• Start date: 2017-01-16
• Primary completion: 2019-10-03
• Completion: 2023-05-08
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: Spain