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Study identifier: NCT07077681 Synced from ClinicalTrials.gov · July 28, 2026
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Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar

Condition: Crohn Disease (CD)  ·  Sponsor: EG Labo

PhaseN/A
Planned participants246
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (11)

Cabinet MedicalAmiens, FranceRecruiting
Chu de La Côte BasqueBayonne, FranceRecruiting
Chu Besançon - Hopital Jean MinjozBesançon, FranceNot Yet Recruiting
Chu La Cavale BlancheBrest, FranceRecruiting
Chu Montpellier - Hopital Saint EloiMontpellier, FranceRecruiting
Chu NantesNantes, FranceRecruiting
Clinique Jules VerneNantes, FranceRecruiting
Institut Des Mici Groupe HospitalierNeuilly-sur-Seine, FranceRecruiting
Chu Lyon SudPierre-Bénite, FranceRecruiting
CHU Rouen NormandieRouen, FranceRecruiting
Chu Nancy BraboisVandœuvre-lès-Nancy, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT07077681