Ustekinumab for mucocutaneous Behçet's syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional, observational cohort with parallel groups collecting routine clinical data on about 208 patients treated with either a ustekinumab biosimilar (n≈104) or apremilast (n≈104). Data are collected retrospectively and prospectively from regular care visits (baseline, week 4, 12, 24, 36 and 52) without additional study-specific visits or procedures. Clinical exams, lab results and disease activity scores (BDCAF, BSAS, PhGA) recorded in medical records will be used to compare outcomes and tolerability between the two cohorts. Inclusion targets adults meeting the 2013 Behçet's criteria with active mucocutaneous manifestations for the ustekinumab cohort and treatment-naïve mucocutaneous patients for the apremilast cohort.

Why it matters

Who can join: the full rules

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

Where it's running

• GHSIF Melun
  Melun, France Recruiting
• APHP_ Hôpital Pitié-Salpêtrière
  Paris, Île-de-France Region, France Recruiting
• CHU BORDEAUX Hôpital Saint-André - Service de médecine interne
  Bordeaux, France Not yet recruiting
• Service de médecine interne-APHP - Henri Mondor
  Créteil, 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

Study contacts

• Study coordinator: DAVID SAADOUN, Professor
• Email: david.saadoun@aphp.fr
• Phone: +33142178042

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Guselkumab vs Ustekinumab for stricturing Crohn's disease

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• Guselkumab for Chinese patients with Crohn's disease who stopped responding to ustekinumab

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  Recruiting at 5 sites Phase 4 Xian-Janssen Pharmaceutical Ltd. · Guangzhou and 4 other locations · NCT07310095

• Reducing ustekinumab dosing for Crohn's disease and ulcerative colitis

  This will try giving ustekinumab less often—changing from every 4 or 8 weeks to every 8 or 12 weeks—to see if people with Crohn's disease or ulcerative colitis in deep remission can stay well.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.