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

NCT06666569 | Completed DMC

• 1 other identifier: IBD-MONITOR
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease and Ulcerative Colitis

Keywords

IBD, Anti-TNFα, Promonitor-IFX/ADL, Promonitor-Anti-IFX/ADL

Outcome Measures

Primary Outcomes (1)

• 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

  32 meses

Study Arms (1)

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.

Device: Use of the test for treatment optimization

Interventions

Use of the test for treatment optimization DEVICE

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.

Intervention Cohort and Clinical Practice Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients of both sexes
• over 18 years of age
• diagnosis of CD/CU confirmed by endoscopy
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Basurto: lead
• PROGENIKA BIOPHARMA, A GRIFOLS Company: collaborator

Study Sites (1)

Basurto University Hospital

Bilbao, Bizkaia, 48013, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leftover serum samples

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 32 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 30, 2024
• Study Start: January 16, 2017
• Primary Completion: October 3, 2019
• Study Completion: May 8, 2023
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

ES (1)