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NCT06666569: IBDMonitor

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

Completed Last updated 30 October 2024
What this trial tests

trial testing Use of the test for treatment optimization in Crohn Disease and Ulcerative Colitis in 209 participants. Completed in 8 May 2023.

Timeline
16 January 2017
Primary endpoint
3 October 2019
8 May 2023

Quick facts

Lead sponsorHospital de Basurto
StatusCompleted
Study typeOBSERVATIONAL
Enrollment209
Start date16 January 2017
Primary completion3 October 2019
Estimated completion8 May 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital de Basurto

Who can join

18 and older, any sex, with Crohn Disease and Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Infliximab and Adalimumab Monitoring versus Clinical Control during Maintenance Therapy in Randomized Patients with Inflammatory Bowel Disease
    Muñoz-Villafranca C, Merino O, Gómez L, Higuera R, et al · · 2025 · DOI 10.21203/rs.3.rs-7537370/v1
  2. Infliximab and Adalimumab Monitoring versus Clinical Control during Maintenance Therapy in Patients with Inflammatory Bowel Disease
    MUÑOZ-VILLAFRANCA MDC, OCHOA OM, GÓMEZ T, HIGUERA R, et al · · 2025 · DOI 10.21203/rs.3.rs-5741968/v1

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Other Hospital de Basurto trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06666569.

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