Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution

Status: Recruiting
Location: See all (11) locations...
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 occurred during follow-up * To describe the profile of patients who discontinued treatment upon their request.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Cabinet Medical
RECRUITING
Amiens
Chu de La Côte Basque
RECRUITING
Bayonne
Chu Besançon - Hopital Jean Minjoz
NOT_YET_RECRUITING
Besançon
Chu La Cavale Blanche
RECRUITING
Brest
Chu Montpellier - Hopital Saint Eloi
RECRUITING
Montpellier
Chu Nantes
RECRUITING
Nantes
Clinique Jules Verne
RECRUITING
Nantes
Institut Des Mici Groupe Hospitalier
RECRUITING
Neuilly-sur-seine
Chu Lyon Sud
RECRUITING
Pierre-bénite
CHU Rouen Normandie
RECRUITING
Rouen
Chu Nancy Brabois
RECRUITING
Vandœuvre-lès-nancy
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 246
Related Therapeutic Areas
Sponsors
Leads: EG Labo

This content was sourced from clinicaltrials.gov