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Ustekinumab in BEhçet's Syndrome STudy

Recruitingn/aAges 18 Years - anyAllGroupe français d'étude des Maladies Inflammatoir…
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In plain words

What the trial is, and whether it could suit you

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'

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

11 sites
CHU BORDEAUX Hôpital Saint-André - Service de médecine interne
Bordeaux, France
Service de médecine interne-APHP - Henri Mondor
Créteil, France
HOPITAL CROIX-ROUSSE - HCL - service de médecine interne
Lyon, France
Hospices civils de Lyon
Lyon, France
GHSIF Melun
Melun, France
AP-HP-Hôpital COCHIN
Paris, France
service de dermatologie - APHP - St Louis
Paris, France
CHU Rouen_Hôpital Charles Nicolle
Rouen, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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