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RECRUITING
NCT07077681

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

Sponsor: EG Labo

View on ClinicalTrials.gov

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.

Official title: Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

246

Start Date

2025-06-02

Completion Date

2027-12-31

Last Updated

2025-07-22

Healthy Volunteers

No

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