Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinu
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
| Condition(s) | Crohn Disease (CD) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 o |
| Who can participate | 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 havin |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | EG Labo |
| Locations | Amiens, France; Bayonne, France; Besançon, France; Brest, France; Montpellier, France; Nantes, France (+5 more sites) |
| Start date | 2025-06-02 |
| NCT ID | NCT07077681 |
| Official listing | https://clinicaltrials.gov/study/NCT07077681 |