Ustekinumab in BEhçet's Syndrome STudy

NCT07244614 | Recruiting

• 2 other identifiers: USBEST2025-A01077-42
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 11

Brief Summary

This non-interventional study is an observational cohort with parallel groups aiming primarily to describe the success of biosimilar of ustekinumab in Behçet's syndrome in whom conventional approaches have failed or are not suitable well tolerated, and then to compare with patients receiving apremilast within routine care. Ustekinumab previously prescribed subcutaneously at 90 mg on Week 0, 4, 12 and 20 within the standard of care. Following non-opposition to participate, patients data will be collected, which will comprise data of the 3-month interval medical visits, except for the first month of treatment, in which the short-term tolerance of treatments is usually assessed (ie, baseline visit, then week 4, 12, 24, 36 and 52). Clinical examination, biological tests and relevant clinical scores (BDCAF, BSAS and PhGA) data that were performed within routine care. No changes to patients' usual care will be made (no additional visits, additional examinations or questionnaires), their safety and well-being remaining therefore unchanged. Data will be collected from the participant's medical record (containing medical reports and examinations, biological tests, nursing records, etc.), for the period of participation in the research, with the only purpose of meeting the objectives of the research. Data will be collected using an electronic 'eCRF observation book on the REDCap platform. The following data will be collected: demographic data (age, sex, weight, height); clinical data (history of the disease, pathology diagnosed, activity of the pathology), treatments, biological data, adverse events. No genetic data will be collected as part of the study. No data will be transferred abroad. No additional questionnaires, examinations or visits will be added by the research. Activity indexes for BS will be calculated as part of routine care. The number, duration and intensity of oral ulcers of patients will be verified by the nurse or the site investigator according to the routine care. Patients' data with active mucocutaneous Behçet's manifestations with an indication of starting apremilast within standard of care (according to AMM and PNDS) will be retrospectively collected in order to establish a retrospective cohort for comparative purposes.

Conditions

Behçet's Syndrome (BS)

Keywords

Behçet's syndrome; biosimilar; ustekinumab; refractory; apremilast

Outcome Measures

Primary Outcomes (1)

• Success at Week 24 will be defined as the absence of active mucocutaneous manifestations

  Success at Week 24 will be defined as the absence of active mucocutaneous manifestations at week 24 without treatment discontinuation due to inefficacy or toxicity.

  Week 24

Secondary Outcomes (13)

• Area under the curve (AUC) for the cumulative number of oral ulcers

  Week 24

• Duration (days) of oral and genital ulcers

  Week 24

• Number of oral and genital ulcers

  Week 24

• Number of painful and swollen joints

  Week 24

• Rate of patients with complete response (ie, no mucocutaneous manifestations), partial response (>50% reduction in overall mucocutaneous manifestations), and no response

  Week 12 and Week 24

Study Arms (2)

Ustekinumab group

patients who have received the Ustekinumab

Apremilast group

patients who have received the Apremilast

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

Two groups will be established in this observational cohort: 1. Patients with active mucocutaneous manifestations of Behçet's syndrome that are either relapsing, refractory or intolerant to conventional treatments, that have received an indication of ustekinumab according to the standard of care of tertiary centres. 2. Patients with active mucocutaneous manifestations of Behçet's syndrome treated by apremilast within standard of care will be also retrospectively collected in order to establish a comparative group.

You may qualify if:

• Age ≥ 18 years old;
• Non-opposition to study;
• Use of contraceptive measures;
• Fulfillment of the international classification criteria for Behçet's disease, revised in 2013;
• Indication for ustekinumab or apremilast within the standard of care of mucocutaneous Behçet's syndrome
• For ustekinumab cohort: Active mucocutaneous manifestations of Behçet's syndrome that are recurrent, intolerant or refractory to colchicine or apremilast, including oral ulcers, genital ulcers, skin lesions (e.g., pseudofolliculitis), and/or inflammatory arthralgia/arthritis.
• For apremilast cohort: recurrent active mucocutaneous manifestations of Behçet's syndrome naïve of treatment.

You may not qualify if:

• Pregnancy;
• Previous treatment failure to ustekinumab;
• Contraindications to ustekinumab, such as:
• Active chronic infections (e.g., active tuberculosis, replicative hepatitis B, HIV, etc.) or malignancies;
• Live vaccins in the past 3 months;
• Severe renal impairment (CrCl \<30mL/min/1,73m²)
• Severe hepatic impairment (transaminases 5 times the upper normal values)
• Severe cytopenias:
• Platelets \< 50 x 103/mm3 Neutrophils \< 1000/mm3 Hemoglobin \< 8 g/Dl

Sponsors & Collaborators

• Groupe français d'étude des Maladies Inflammatoires de loeil: lead

Study Sites (11)

CHU BORDEAUX Hôpital Saint-André - Service de médecine interne

Bordeaux, France

NOT YET RECRUITING

Service de médecine interne-APHP - Henri Mondor

Créteil, 94000, France

NOT YET RECRUITING

HOPITAL CROIX-ROUSSE - HCL - service de médecine interne

Lyon, France

NOT YET RECRUITING

Hospices civils de Lyon

Lyon, France

NOT YET RECRUITING

GHSIF Melun

Melun, 77000, France

RECRUITING

AP-HP-Hôpital COCHIN

Paris, France

NOT YET RECRUITING

service de dermatologie - APHP - St Louis

Paris, France

NOT YET RECRUITING

CHU Rouen_Hôpital Charles Nicolle

Rouen, 76000, France

NOT YET RECRUITING

CHU de Rouen - service dermatologie

Rouen, France

NOT YET RECRUITING

APHP_Hopital Lariboisière

Paris, Île-de-France Region, 75010, France

ACTIVE NOT RECRUITING

APHP_ Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

RECRUITING

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Central Study Contacts

DAVID SAADOUN, Professor

CONTACT

+33142178042; david.saadoun@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 24, 2025
• Study Start: September 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (11)