Determination of Ustekinumab Levels in Patients With Crohn's Disease

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Crohn Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05057832

FIS-UST-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

95 participants in 1 patient group

Cases

Description:

Patients treated with Ustekinumab.