Switching adults with Crohn's disease from Stelara (ustekinumab) to the biosimilar Uzpruvo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, multicenter observational cohort following adults with Crohn's disease whose physician and who have agreed to switch from Stelara® to the biosimilar Uzpruvo®. The switch is made as part of routine care, with physicians keeping full discretion over dosing and treatment decisions and patients completing online self-assessment questionnaires. The primary endpoint is maintenance on the biosimilar at 12 months without returning to the reference product, with secondary outcomes including quality of life, clinical remission rates, tolerability, patient satisfaction, and reasons for discontinuation. No extra medical procedures are mandated beyond standard follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient treated with ustekinumab with intervals between injections less than 8 weeks
* 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.

Where it's running

• Cabinet Medical
  Amiens, France Recruiting
• Chu de La Côte Basque
  Bayonne, France Recruiting
• Chu La Cavale Blanche
  Brest, France Recruiting
• Chu Montpellier - Hopital Saint Eloi
  Montpellier, France Recruiting
• Chu Nantes
  Nantes, France Recruiting
• Clinique Jules Verne
  Nantes, France Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reducing ustekinumab dosing for Crohn's disease and ulcerative colitis

  This will try giving ustekinumab less often—changing from every 4 or 8 weeks to every 8 or 12 weeks—to see if people with Crohn's disease or ulcerative colitis in deep remission can stay well.

  Recruiting Phase 4 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07303686

• Switching to guselkumab for adults with active IBD after ustekinumab

  We will try guselkumab (Tremfya) in adults with active IBD whose symptoms didn't improve enough on ustekinumab.

  Recruiting at 12 sites TIDHI Innovation Inc. · Calgary, Alberta and 13 other locations · NCT07245394

• Combining Ustekinumab with Semi-Enteral Nutrition for Crohn's Disease Before Surgery

  This study is testing if combining a medication called Ustekinumab with a special diet can help adults with Crohn's Disease feel better and get healthier before surgery.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT06912815

• Reduce ultra-processed foods to help kids with Crohn's stay in remission longer

  This study tests whether and how reducing ultra-processed foods with dietitian guidance helps children and teens with Crohn's disease stay in remission longer.

  Recruiting University Hospital, Motol · Prague and 1 other locations · NCT07884045

• Endoscopic stricturotomy vs balloon dilation for small bowel Crohn’s stricture

  This trial tests whether endoscopic stricturotomy can be safely and effectively used to treat small bowel fibrotic strictures in Crohn’s disease, compared with endoscopic balloon dilation.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07833332

• Prediction of postoperative recurrence in Crohn's disease after surgery

  A multicenter study will test a multimodal model to predict which Crohn's patients are likely to have disease recur after intestinal resection.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07824791

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.