Informations générales (source: ClinicalTrials.gov)
Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
Observational
EG Labo (Voir sur ClinicalTrials)
juin 2025
décembre 2027
01 août 2026
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 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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| INSTITUT HOSPITALIER FRANCO-BRITANIQUE | Carmen STEFANESCU, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Besançon - Hopital Jean Minjoz - 25000 - Besançon - France | LUCINE VUITTON, MD PhD | Contact (sur clinicalTrials) | |||
| Chu La Cavale Blanche - Brest - France | Catherine NOEL, MD | Contact (sur clinicalTrials) | |||
| Chu Lyon Sud - Pierre-Bénite - France | Stéphane NANCEY, MD | Contact (sur clinicalTrials) | |||
| Chu Montpellier - Hopital Saint Eloi - 34295 - Montpellier - France | Romain ALTWEGG, MD | Contact (sur clinicalTrials) | |||
| Chu Nancy Brabois - 54500 - Vandœuvre-lès-Nancy - France | Bénédicte CARON, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen Normandie - 76000 - Rouen - France | Nicolas Richard, Dr | Contact (sur clinicalTrials) | |||
| Clinique Jules Verne - Nantes - France | Marie FREYSSINET, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cabinet Medical - 80090 - Amiens - France | Julien LOREAU, MD | Contact (sur clinicalTrials) | |||
| Chu de La Côte Basque - 64109 - Bayonne - France | Félix GOUTORBE, MD | Contact (sur clinicalTrials) | |||
| Chu Nantes - 44093 - Nantes - France | Arnaud BOUREILLE, MD PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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.