Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission in Patients With Crohn's Disease.

NCT07100093 | Completed DMC

• 1 other identifier: PI-4732
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, non-commercial, multicenter study will be conducted in a cohort of patients initiating induction therapy and a cohort of patients with stable treatment with ustekinumab.

Conditions

Ustekinumab Serum Levels in Patients With Crohn´s Disease

Keywords

Ustekinumab; Serum levels; Crohn´s disease

Outcome Measures

Primary Outcomes (1)

• biological remission

  association between serum levels of ustekinumab and biological remission in induction

  week 8 and week 16

Study Arms (2)

Induction

Patients with an established diagnosis of Crohn's disease according to the usual criteria (clinical, analytical, endoscopic, radiological and/or histological) with inflammatory activity, who initiate treatment with ustekinumab for induction of remission. Activity will be considered the presence of clinical activity (Harvey-Bradshaw index ≥5) and/or elevation of fecal calprotectin (≥ 250µg/g; ≥100 in case of interventional CD) and/or presence of endoscopic activity (SES-CD ≥3).

Procedure: Drug serum levels

Maintenance

Patients with an established diagnosis of Crohn's disease according to usual criteria (clinical, analytical, endoscopic, radiological and/or histological) on maintenance treatment with ustekinumab stably for a minimum of 6 months.

Procedure: Drug serum levels

Interventions

Drug serum levels PROCEDURE

Ustekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology.

Induction; Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an established diagnosis of CD based on standard criteria (clinical, laboratory, endoscopic, radiological, and/or histological) who are starting treatment with ustekinumab (induction cohort) or who are undergoing maintenance treatment with ustekinumab (maintenance cohort) on a stable basis (minimum of 6 months) will be included.

You may qualify if:

• Patients with an established diagnosis of CD according to standard criteria (clinical, analytical, endoscopic, radiological, and/or histological) with inflammatory activity, who begin treatment with ustekinumab for remission induction. Activity will be considered to be the presence of clinical activity (Harvey-Bradshaw index ≥5) and/or elevated fecal calprotectin (≥ 250μg/g; ≥100 in cases of surgically treated CD) and/or the presence of endoscopic activity (SES-CD ≥3).
• Patients with a confirmed diagnosis of CD according to standard criteria (clinical, analytical, endoscopic, radiological, and/or histological) undergoing stable maintenance treatment with ustekinumab for at least 6 months.

You may not qualify if:

• Patients in whom ustekinumab is indicated for the prevention of post-surgical recurrence.
• Patients in whom ustekinumab is indicated for the control of perianal disease.
• Patients in whom ustekinumab is indicated for the control of extraintestinal manifestations.
• Pregnant women.
• Patients who are unable to understand the nature of the study, the procedures to be followed, or who are not able to sign an informed consent form.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 3, 2025
• Study Start: July 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: February 25, 2022
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)