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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
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

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cabinet Medical
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
Chu de La Côte Basque
Coordinator of this site? Confirm its status
BayonneFranceRecruiting
CHU Besancon - Hopital Jean Minjoz
Coordinator of this site? Confirm its status
BesançonFranceNot yet recruiting
Chu La Cavale Blanche
Coordinator of this site? Confirm its status
BrestFranceRecruiting
CHU Montpellier - Hôpital Saint Eloi
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
CHU Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Clinique Jules Verne
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Institut Des Mici Groupe Hospitalier
Coordinator of this site? Confirm its status
Neuilly-sur-SeineFranceRecruiting
CHU Lyon Sud
Coordinator of this site? Confirm its status
Pierre-BéniteFranceRecruiting
CHU Rouen Normandie
Coordinator of this site? Confirm its status
RouenFranceRecruiting
CHU Nancy-Brabois
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.