Determination of Ustekinumab Levels in Patients With Croh... | NCT05057832

Studies
Determination of Ustekinumab Levels in Patients With Crohn's Disease

NCT05057832

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown status

Last Update Posted

Nov 17, 2021Actual

Enrollment

95Estimated

Phase

Not provided

Conditions

Crohn Disease

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Feb 1, 2022Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Sep 16, 2021

First Submission Date that Met QC Criteria

Sep 24, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2021

Last Update Posted Date

Nov 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Estimated

Label	Type	Description	Intervention Names
Cases		Patients treated with Ustekinumab.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients treated with ustekinumab who have had their levels measured will be included.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Federico Arguelles Arias	Contact	955 00 80 00		farguelles@telefonica.net
Carlos García Pérez	Contact	955 04 31 27		administracion.eecc.hvm.sspa@juntadeandalucia.es

Overall Officials

Name	Affiliation	Role
Federico Arguelles Arlas	Hospital Universitario Virgen Macarena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Virgen de Macarena	Recruiting	Seville		41009	Spain

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided