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Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
Sponsor: EG Labo
Summary
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.
Official title: Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
246
Start Date
2025-06-02
Completion Date
2027-12-31
Last Updated
2025-07-22
Healthy Volunteers
No
Conditions
Locations (11)
Cabinet Medical
Amiens, France
Chu de La Côte Basque
Bayonne, France
Chu Besançon - Hopital Jean Minjoz
Besançon, France
Chu La Cavale Blanche
Brest, France
Chu Montpellier - Hopital Saint Eloi
Montpellier, France
Chu Nantes
Nantes, France
Clinique Jules Verne
Nantes, France
Institut Des Mici Groupe Hospitalier
Neuilly-sur-Seine, France
Chu Lyon Sud
Pierre-Bénite, France
CHU Rouen Normandie
Rouen, France
Chu Nancy Brabois
Vandœuvre-lès-Nancy, France