Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGOBSERVATIONAL

Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar

Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 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.

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