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Determination of Ustekinumab Levels in Patients With Crohn's Disease

NCT ID: NCT05057832

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Crohn Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients treated with Ustekinumab.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federico Arguelles Arlas

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

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Hospital Universitario Virgen de Macarena

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Federico Arguelles Arias

Role: CONTACT

Phone: 955 00 80 00

Email: [email protected]

Carlos García Pérez

Role: CONTACT

Phone: 955 04 31 27

Email: [email protected]

Facility Contacts

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Federico Arguelles Arla

Role: primary

Carlos García Pérez

Role: backup

Other Identifiers

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FIS-UST-2021-01

Identifier Type: -

Identifier Source: org_study_id