Tests a biosimilar form of ustekinumab in adults with Crohn disease
Follows adults with Crohn disease who switched from Stelara to a biosimilar ustekinumab.
Key facts
- Who runs it
- EG Labo
- Where
- Amiens, Bayonne, Besançon, Brest, Montpellier, Nantes, Neuilly-sur-Seine, Pierre-Bénite, Rouen, and Vandœuvre-lès-Nancy, FranceSee the 11 sites
- Trial code
- Registry title
- Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
- Status
- Recruiting
- People taking part
- 246 people, planned
- Started
- 2 Jun 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Observational
- Record updated
- 22 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe Crohn's disease in stable remission on Stelara®, who agreed with their doctor to switch to the biosimilar Uzpruvo®.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Moderate to severe Crohn's disease in stable remission (stable ustekinumab dose over the last 24 weeks, no corticosteroids for at least 3 months).
- Earlier treatment
- Treated with Stelara® in a pre-filled syringe, with 8 or 12 weeks between injections. No corticosteroids for at least 3 months.
- Biomarker or test result
- At least one of these: PCR < 5 mg/l, Calprotectin < 250 μg/g, or Harvey-Bradshaw index < 5.
Main reasons for not taking part
- Ustekinumab injections less than 8 weeks apart
- Ustekinumab in a pre-filled pen
- Taking part in an interventional clinical trial at the same time
- Cannot follow the study procedures or fill in the questionnaires (for example, poor French)
- Under legal protection, guardianship or curatorship
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- Cabinet MedicalAmiens, FranceContact: Julien LOREAU, MDTaking people
- Chu de La Côte BasqueBayonne, FranceContact: Félix GOUTORBE, MDTaking people
- CHU Besancon - Hopital Jean MinjozBesançon, FranceContact: LUCINE VUITTON, MD PhDNot yet recruiting
- Chu La Cavale BlancheBrest, FranceContact: Catherine NOEL, MDTaking people
- CHU Montpellier - Hôpital Saint EloiMontpellier, FranceContact: Romain ALTWEGG, MDTaking people
- CHU NantesNantes, FranceContact: Arnaud BOUREILLE, MD PhDTaking people
- Clinique Jules VerneNantes, FranceContact: Marie FREYSSINET, MDTaking people
- Institut Des Mici Groupe HospitalierNeuilly-sur-Seine, FranceContact: Carmen STEFANESCU, MDTaking people
- CHU Lyon SudPierre-Bénite, FranceContact: Stéphane NANCEY, MDTaking people
- CHU Rouen NormandieRouen, FranceContact: Nicolas Richard, DrTaking people
- CHU Nancy-BraboisVandœuvre-lès-Nancy, FranceContact: Bénédicte CARON, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
* 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 factors associated with the maintenance of the biosimilar * To evaluate the evolution of patients' quality of life * To assess the rate of maintenance of clinical remission at M12 * To describe the acceptability of the biosimilar treatment by patients * To evaluate patient satisfaction * To evaluate treatment tolerance * To describe the reasons for treatment discontinuation that occurred during follow-up * To describe the profile of patients who discontinued treatment upon their request.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
- Plain-language title
- Tests a biosimilar form of ustekinumab in adults with Crohn diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 July 2025