Clinical trial NCT06666569: Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL in Patients With IBD
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease and Ulcerative Colitis
Keywords: IBD, Anti-TNFα, Promonitor-IFX/ADL, Promonitor-Anti-IFX/ADL
Lead sponsor: Hospital de Basurto
Sponsor class: OTHER
Collaborators: name: PROGENIKA BIOPHARMA, A GRIFOLS Company
First posted: 2024-10-30
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Pharmacological management of IBD
timeFrame: 32 meses
Secondary outcomes:
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Basurto University Hospital
state: Bizkaia
Study officials:
References: