Ustekinumab in BEhçet's Syndrome STudy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Upadacitinib for Refractory Behcet's Syndrome

NCT07080346

Behcet Syndrome

COMPLETED PHASE2

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

NCT05767047

Behçet's Disease Juvenile Psoriatic Arthritis

RECRUITING PHASE3

Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant

NCT00188825

COPD Emphysema Alpha-1 Antitrypsan Deficiency

COMPLETED PHASE3

Ustekinumab for the Treatment of Giant Cell Arteritis

NCT02955147

Giant Cell Arteritis Temporal Arteritis Horton's Disease

TERMINATED PHASE1/PHASE2

Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease

NCT03371095

Behcet's Disease Vasculitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This non-interventional study is an observational and comparative cohort aiming to describe the success of biosimilar of ustekinumab in Behçet's syndrome in whom conventional approaches have failed or are not suitable well tolerated. Data on 208 patients is expected to be identified as follows:

* data of 104 patients will be collected from patients who have received the ustekinumab
* data of 104 patients will be collected from patients who have received the apremilast.

Ustekinumab is usually 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 retrospectively according to local clinical practices and usual care, which usually comprises 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). Available data on clinical examination, biological tests and relevant clinical scores (BDCAF, BSAS and PhGA) that are performed within routine care will be retrieved. 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 are usually calculated as part of routine care. The number, duration and intensity of oral ulcers of patients might 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 will be also retrospectively collected in order to establish a comparative group, using the same parameters above mentioned

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behçet's Syndrome (BS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ustekinumab group

patients who have received the Ustekinumab

No interventions assigned to this group

Apremilast group

patients who have received the Apremilast

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Due to its fluctuant characteristics over time, active oral ulcers are defined as two or more oral ulcers over the month preceding inclusion and must have occurred at least three times in the previous 12-month period, despite the previous use of colchicine

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No