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NCT06666569: IBDMonitor
Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL in Patients With IBD
trial testing Use of the test for treatment optimization in Crohn Disease and Ulcerative Colitis in 209 participants. Completed in 8 May 2023.
3 October 2019
Quick facts
| Lead sponsor | Hospital de Basurto |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 209 |
| Start date | 16 January 2017 |
| Primary completion | 3 October 2019 |
| Estimated completion | 8 May 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Use of the test for treatment optimization
Conditions studied
- Crohn Disease and Ulcerative Colitis — all drugs for Crohn Disease and Ulcerative Colitis →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT06666569
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Hospital de Basurto trials
Trials by the same sponsor.
- NCT06650943 — Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP) · NA · recruiting
- NCT03424447 — Stimulation of the Efferent Loop Before Loop Ileostomy Closure · Phase 2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06666569 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Basurto
- Last refreshed: 30 October 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing