Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
NCT ID: NCT07077681
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
246 participants
OBSERVATIONAL
2025-06-02
2027-12-31
Brief Summary
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* 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.
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Detailed Description
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This observational study does not alter the physician-patient relationship or standard patient care. Physicians retain freedom in their prescriptions and follow-up procedures; no specific procedures or tests are required of patients beyond the completion of self-assessment questionnaires. The study is longitudinal, and the proposed assessments remain within the framework of the patients' standard follow-up with their physician.
This study is classified as RIPH 3 (minimally or not at all interventional).
The conduct of the treatment (dosage, administration schedule, etc.) is left to the discretion of the investigating physician in compliance with the MA, according to their clinical practice and the patient's therapeutic history. Similarly, the investigating physician remains the sole judge of the continuation or interruption of ustekinumab or its replacement by another biotherapy or by any other treatment. All treatments associated with ustekinumab as part of the management of the condition that prompted biotherapy that will be prescribed during the study must be reported in the observation log.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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EG Labo
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Other Identifiers
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Etude ATLAS France 2025
Identifier Type: -
Identifier Source: org_study_id
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