RecruitingNCT07077681

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

Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution


Sponsor

EG Labo

Enrollment

246 participants

Start Date

Jun 2, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether switching from Stelara® (ustekinumab) to a biosimilar version called Uzpruvo® is acceptable to patients with Crohn's disease who are in stable remission, and whether they continue to stay well after the switch. **You may be eligible if...** - You are 18 years or older - You have moderate-to-severe Crohn's disease being treated with Stelara® (ustekinumab) via pre-filled syringe every 8 or 12 weeks - You are in stable remission — meaning your dose has not changed in 24 weeks and you have been off steroids for at least 3 months - You and your doctor have already agreed to switch from Stelara® to Uzpruvo® - Your inflammatory markers (CRP, calprotectin) and symptom scores are within acceptable ranges **You may NOT be eligible if...** - You are under 18 years old - Your Crohn's disease is not in stable remission - You have not agreed to participate or allow use of your health data Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT07077681


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