NCT07077681Recruiting
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 246 (estimated)
- First submitted
- 30 Jun 2025
- Start date
- Jun 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- EG Labo
- Diseases
- Crohn's disease
- NCT number
- NCT07077681
What you commit to
- Study type: Observational
- Planned participants: 246
- From Jun 2025 to the primary completion date, Apr 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient treated with ustekinumab with intervals between injections less than 8 weeks
- Patients treated with ustekinumab in a pre-filled pen
Other
- 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.
Who the study is looking for
- 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 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cabinet Medical Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Chu de La Côte Basque Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| CHU Besancon - Hopital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Not yet recruiting |
| Chu La Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| CHU Montpellier - Hôpital Saint Eloi Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Clinique Jules Verne Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut Des Mici Groupe Hospitalier Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Recruiting |
| CHU Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| CHU Rouen Normandie Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| CHU Nancy-Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.