Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission in Patients With Crohn's Disease.
NCT ID: NCT07100093
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
100 participants
OBSERVATIONAL
2021-07-01
2022-02-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Determination of Ustekinumab Levels in Patients With Crohn's Disease
NCT05057832
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
NCT01369329
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
NCT03107793
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
NCT03782376
Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Cohort Study
NCT06802887
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Working hypothesis: Serum Ustekinumab levels in Crohn's disease patients are correlated with clinical, biochemical and endoscopic/radiological response/remission.
Patients with an established diagnosis of Crohn's disease by usual criteria (clinical, analytical, endoscopic, radiological and/or histological) who initiate treatment with Ustekinumab (induction cohort) or who are on maintenance treatment with Ustekinumab (maintenance cohort) in a stable dosis (a minimum of 6 months) will be included.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
Drug serum levels
Ustekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology.
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.
Drug serum levels
Ustekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Drug serum levels
Ustekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario La Paz
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
María Dolores Martín Arranz, PhD
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario La Paz
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI-4732
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.