Ustekinumab Serum Levels in Patients With Crohn´s DiseaseUSTECRONCT07100093
Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission in Patients With Crohn's Disease.
An observational study of Ustekinumab Serum Levels in Patients With Crohn´s Disease, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ustekinumab Serum Levels in Patients With Crohn´s Disease
- What is being tested?
- Drug serum levels
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2021to 25 Feb 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The present study aims to evaluate the association between serum levels (trough) of Ustekinumab and clinical, biological, endoscopic and radiological response/remission in patients with Crohn's disease, in order to determine threshold levels at induction and maintenance that may be predictors of efficacy.
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.
- Being tested
- Drug serum levels
- Keywords
- Ustekinumab, Serum levels, Crohn´s disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug serum levelsProcedure or surgery
Ustekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Drug serum levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
biological remission
association between serum levels of ustekinumab and biological remission in induction
Measured: week 8 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jul 2021
- Primary completion30 Dec 2021
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ustekinumab Serum Levels in Patients With Crohn´s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100093
- Sponsor's protocol ID
- PI-4732
- Acronym
- USTECRO
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study on the Association Between Serum Ustekinumab Levels and Clinical, Biological and Endoscopic Remission in Patients With Crohn's Disease.
- ClinicalTrials.gov ID
- NCT07100093
- Acronym / sponsor ID
- USTECRO / PI-4732
- Keywords
- Ustekinumab, Serum levels, Crohn´s disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study aims to evaluate the association between serum levels (trough) of Ustekinumab and clinical, biological, endoscopic and radiological response/remission in patients with Crohn's disease, in order to determine threshold levels at induction and maintenance that may be predictors of efficacy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction | – | Procedure: Drug serum levelsPatients 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). |
| Maintenance | – | Procedure: Drug serum levelsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug serum levelsUstekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology. | Procedure or surgery | Induction, Maintenance |
Primary outcome
biological remission
Time frame: week 8 and week 16
association between serum levels of ustekinumab and biological remission in induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ustekinumab Serum Levels in Patients With Crohn´s Disease, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biological remission (time frame: week 8 and week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.