Observational study on patients switching to a biosimilar treatment for Crohn's disease and plaque psoriasis

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

ROLL'YN-UST is an observational study that includes adult patients with Crohn's disease or plaque psoriasis who have been in clinical remission for at least three months and have been treated with the reference biotherapy for at least six months. The study aims to evaluate the maintenance of clinical remission and patient satisfaction after switching to STEQEYMA®, a biosimilar of ustekinumab. Patients will be monitored for 12 months following the switch, with assessments of their clinical status and satisfaction at six and twelve months. This study is significant as it addresses the real-world effectiveness of a newly approved biosimilar treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be an adult (18 years of age or older at the time of inclusion) followed in specialty care and diagnosed with of one of the following conditions: Crohn's disease, Plaque psoriasis
* Treated for at least 6 months prior to inclusion with the reference Ustekinumab for the pathology in question: Crohn's disease, Plaque psoriasis
* Stable for at least 3 months according to the prescribing physician and in clinical remission according to the specific disease activity score.
* For whom the specialist has decided to switch to the biosimilar treatment developed and marketed by Celltrion on the day of inclusion (shared medical decision independent of the study)
* Have an email address.
* Have a mobile phone number.
* Be able to understand and complete questionnaires in French.
* Not opposed to participating in the study.
* Be affiliated to a French Social Security scheme or be a beneficiary of such a scheme.

Exclusion Criteria:

* Patients under guardianship or otherwise deprived of their freedom.
* Pregnant women or women of childbearing potential who wish to become pregnant while taking one of the study treatments.
* Patients participating at the time of inclusion in a clinical trial or other clinical study that prohibits simultaneous participation in other studies.
* Contraindication to study products.

Where it's running

• CHU Amiens
  Amiens, France Recruiting

Study contacts

• Study coordinator: Salim BENKHALIFA, MD
• Email: etudescliniques_fr@celltrionhc.com
• Phone: +33 1 71 25 27 00

Similar studies

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

• Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab

  This study tests whether guselkumab can help Chinese patients with active Crohn's disease who initially responded to ustekinumab but later lost response.

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• Long-term safety of deucravacitinib versus ustekinumab for plaque psoriasis (PRAGMATYK)

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• Comparing dual-target therapy with intensified Ustekinumab for Crohn's disease

  This study is testing if a new combination treatment of Ustekinumab and Upadacitinib can help people with Crohn's disease feel better compared to a higher dose of Ustekinumab alone.

  Recruiting Phase 4 Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT06520397

• Investigating how ustekinumab distributes in inflamed tissues for Crohn's disease and psoriasis

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• Evaluating Ustekinumab for Treating Stricturing Crohn's Disease

  This study is testing if ustekinumab can help people with moderate-to-severe Crohn's disease who have blockages in their intestines feel better over a two-year period.

  Recruiting at 8 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Beijing, Beijing Municipality and 7 other locations · NCT05387031

• Assessing the long-term safety of ustekinumab compared to other biologics for Crohn's disease and ulcerative colitis

  This study is testing how safe the drug ustekinumab is compared to other biologic treatments for adults with Crohn's disease or ulcerative colitis over the long term.

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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.