ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar

NCT06997055 | Recruiting

• 2 other identifiers: CTHC-CTP43-22024-A02471-46
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.

Conditions

Crohn Disease; Plaque Psoriasis

Keywords

Biosimilar; ustekinumab

Outcome Measures

Primary Outcomes (1)

• Maintenance of remission, 12 months after initiation of biosimilar treatment

  Percentage of patients still in clinical remission 12 months after initiation of biosimilar treatment according to the definitions used in the inclusion criteria.

  12 months

Study Arms (2)

CD group

Switch from ustekinumab originator in patients with Crohn's disease

Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg

Psoriasis Group

Switch from ustekinumab originator in patients with Plaque Psoriasis

Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg

Interventions

Ustekinumab 45 mg DRUG

biosimilar

CD group; Psoriasis Group

Ustekinumab 90 mg DRUG

biosimilar

CD group; Psoriasis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult dermatology or gastroenterology patients presenting a diagnosis for any of the following pathologies: * Crohn's Disease * Plaque Psoriasis

You may qualify if:

• Stable for at least 3 months according to the prescribing physician and in clinical remission according to the specific disease activity score.
• 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.

You may not qualify if:

• 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.
• Contraindication to study products.

Sponsors & Collaborators

• Celltrion HealthCare France: lead
• Sanoia: collaborator

Study Sites (1)

CHU Amiens

Amiens, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Salim BENKHALIFA, MD

CONTACT

+33 1 71 25 27 00; etudescliniques_fr@celltrionhc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)