Actively Recruiting
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
Led by EG Labo · Updated on 2025-07-22
246
Participants Needed
11
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 product guidelines with injections every 8 or 12 weeks
- Patient presenting at least one of these criteria: PCR < 5 mg/l, Calprotectin < 250 bcg/g, or Harvey-Bradshaw index < 5
- Patient in stable remission with stable ustekinumab dose over the last 24 weeks and no corticosteroids for at least 3 months
- Patient for whom the physician has decided to replace Stelara� with Uzpruvo� before inclusion
- Patient having internet access to complete online questionnaires
You will not qualify if you...
- Patient treated with ustekinumab with injections less than every 8 weeks
- Patient treated with ustekinumab using a pre-filled pen
- Patient currently enrolled in an interventional clinical trial
- Patient refusing or unable to comply with study follow-up (unreachable by phone, unable to fill questionnaires, or poor French language skills)
- Patient under legal protection, guardianship, or curatorship
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Cabinet Medical
Amiens, France, 80090
Actively Recruiting
2
Chu de La Côte Basque
Bayonne, France, 64109
Actively Recruiting
3
Chu Besançon - Hopital Jean Minjoz
Besançon, France, 25000
Not Yet Recruiting
4
Chu La Cavale Blanche
Brest, France
Actively Recruiting
5
Chu Montpellier - Hopital Saint Eloi
Montpellier, France, 34295
Actively Recruiting
6
Chu Nantes
Nantes, France, 44093
Actively Recruiting
7
Clinique Jules Verne
Nantes, France
Actively Recruiting
8
Institut Des Mici Groupe Hospitalier
Neuilly-sur-Seine, France, 92200
Actively Recruiting
9
Chu Lyon Sud
Pierre-Bénite, France
Actively Recruiting
10
CHU Rouen Normandie
Rouen, France, 76000
Actively Recruiting
11
Chu Nancy Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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