Crohn'sRecruiting
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
Observational · No treatment assigned · 11 sites · EG Labo
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patient aged 18 years or older
- Patient who has agreed to participate in the study and does not oppose the use of their health data
- Patient with moderate to severe Crohn's disease treated with Stelara® in a pre-filled syringe according to the summary of product characteristics (SPC) with intervals of 8 or 12 weeks between injections
Plus 3 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 246 participants are expected to take part.
- Start date: 2025-06-02.
- Main results expected around 2026-04-30 (estimate from the record).
- 11 study sites listed (10 marked recruiting) in France.
Main thing being measured
- maintenance of treatment (Month 12)
In the researchers’ words
In a population of adult patients followed for Crohn's disease, who had previously agreed to replace Stelara® with a biosimilar of ustekinumab (Uzpruvo®) and were followed over a period of 12 months under usual medical practice conditions. * Main objective: To assess the maintenance of the biosimilar of ustekinumab at 12 months without returning to the reference treatment * Secondary objectives: * To describe the…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | EG Labo |
| Enrollment | 246 (estimated) |
| Start date | 2025-06-02 |
| Primary completion (est.) | 2026-04-30 |
| First posted | 2025-07-22 |
| Last updated | 2025-07-22 |
| Official title | Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution |
| ClinicalTrials.gov ID | NCT07077681 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Patient aged 18 years or older * Patient who has agreed to participate in the study and does not oppose the use of their health data * Patient with moderate to severe Crohn's disease treated with Stelara® in a pre-filled syringe according to the summary of product characteristics (SPC) with intervals of 8 or 12 weeks between injections * Patients presenting at least one of the following objective criteria: o PCR < 5 mg/l o Calprotectin < 250 μg/g o Harvey-Bradshaw index < 5 * Patient in stable remission (defined by a stable ustekinumab dosage over the last 24 weeks and absence of corticosteroids for at least 3 months)• Patient for whom the investigator physician, prior to inclusion, has decided with their agreement, to replace Stelara® with Uzpruvo® * Patient having internet access enabling them to complete online questionnaires Exclusion Criteria: * Patient treated with ustekinumab with intervals between injections less than 8 weeks * Patients treated with ustekinumab in a pre-filled pen * Patient included in an interventional clinical trial at the time of inclusion * Patient refusing or unable to comply with the study follow-up procedures (patient unreachable by phone, unable to fill out the self-questionnaire or poorly speaking French...) * Patient under legal protection, under guardianship or under curatorship.
Locations (11)
| Site | City | Country | Site status |
|---|---|---|---|
| Cabinet Medical | Amiens | France | Recruiting |
| Chu de La Côte Basque | Bayonne | France | Recruiting |
| Chu Besançon - Hopital Jean Minjoz | Besançon | France | Not yet recruiting |
| Chu La Cavale Blanche | Brest | France | Recruiting |
| Chu Montpellier - Hopital Saint Eloi | Montpellier | France | Recruiting |
| Chu Nantes | Nantes | France | Recruiting |
| Clinique Jules Verne | Nantes | France | Recruiting |
| Institut Des Mici Groupe Hospitalier | Neuilly-sur-Seine | France | Recruiting |
| Chu Lyon Sud | Pierre-Bénite | France | Recruiting |
| CHU Rouen Normandie | Rouen | France | Recruiting |
| Chu Nancy Brabois | Vandœuvre-lès-Nancy | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.