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

NCT06666569 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 209

Last updated 2024-10-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • PROGENIKA BIOPHARMA, A GRIFOLS Company

    collaborator UNKNOWN

  • Hospital de Basurto

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2019-10-03
Completion
2023-05-08

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666569 on ClinicalTrials.gov