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

Recruiting now

Conditions studied: Crohn Disease (CD)

In brief

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.

Key facts

Study ID

NCT07077681

Run by

EG Labo

People needed

246

Starts

2025-06-02

Expected to finish

2027-12-31

Last updated by the study team

2025-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Chu Nancy Brabois — Vandœuvre-lès-Nancy, France (enrolling)
• Chu de La Côte Basque — Bayonne, France (enrolling)
• Cabinet Medical — Amiens, France (enrolling)
• Chu La Cavale Blanche — Brest, France (enrolling)
• Chu Montpellier - Hopital Saint Eloi — Montpellier, France (enrolling)
• Chu Nantes — Nantes, France (enrolling)
• Clinique Jules Verne — Nantes, France (enrolling)
• Institut Des Mici Groupe Hospitalier — Neuilly-sur-Seine, France (enrolling)
• Chu Lyon Sud — Pierre-Bénite, France (enrolling)
• CHU Rouen Normandie — Rouen, France (enrolling)
• Chu Besançon - Hopital Jean Minjoz — Besançon, France

Full record on ClinicalTrials.gov

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