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Determination of Ustekinumab Levels in Patients With Crohn's Disease

Determination of Ustekinumab Levels in Patients With Crohn's Disease: Use in Clinical Practice

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05057832
Acronym
Ustekinumab
Enrollment
95
Registered
2021-09-27
Start date
2021-05-01
Completion date
2022-02-01
Last updated
2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Brief summary

Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

Detailed description

Prospective follow-up observational study carried out with patients from the Virgen de Macarena University Hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.

Interventions

None listed

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Over 18 years. * Patients treated with ustekinumab in induction and maintenance phase. * They must agree to participate in the clinical study, having previously signed the informed consent.

Exclusion criteria

* Any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Determine breakpoints.Up to 44 weeks.To determine the breakpoints for ustekinumab levels between which clinical remission is expected in patients with inflammatory bowel disease.

Countries

Spain

Contacts

Primary ContactFederico Arguelles Arias
farguelles@telefonica.net955 00 80 00
Backup ContactCarlos García Pérez
administracion.eecc.hvm.sspa@juntadeandalucia.es955 04 31 27

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026