Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
Recruiting · NCT07077681 · Observational (researchers observe without assigning treatment) · Lead sponsor: EG Labo
View the official record on ClinicalTrials.gov →What this trial is about
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 can take part
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.
Where it is running
11 locations listed.
- 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