Observational study on patients switching to a biosimilar treatment for Crohn's disease and plaque psoriasis
ROLL'YN-UST: Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Steqeyma®, un Biosimilaire de l'ustékinumab
This study is testing if switching to a new biosimilar treatment for Crohn's disease and plaque psoriasis helps patients stay in remission and feel satisfied with their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celltrion HealthCare France Industry-sponsored |
| Drugs / interventions | Ustekinumab |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06997055 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Crohn's disease or plaque psoriasis who have been stable on reference ustekinumab for at least six months.
Not a fit: Patients who are not in clinical remission or have not been treated with the reference ustekinumab for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and patient satisfaction of switching to a biosimilar treatment for chronic inflammatory diseases.
How similar studies have performed: Other studies have shown success with biosimilars in similar conditions, indicating a promising approach for this treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Salim BENKHALIFA, MD
- Email: etudescliniques_fr@celltrionhc.com
- Phone: +33 1 71 25 27 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.