Combining tocilizumab and tofacitinib for treating vascular 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 project evaluates the efficacy and safety of combining glucocorticoids with either tocilizumab or tofacitinib compared to the traditional treatment of glucocorticoids with cyclophosphamide for vascular Behçet's syndrome. The study is a Phase IIb, multi-center, randomized, open-label trial where patients will be assigned to one of three treatment groups. The primary endpoint is the complete remission rate at 24 weeks, with follow-ups every 4 to 6 weeks. The study also aims to identify biomarkers related to the response to treatment, enhancing precision in diagnosis and therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1． Understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.

2\. Male and female subjects aged 18-65 years.

3． Fulfill the 2013 International Classification Criteria for Behcet's Disease (ICBD).

4． Patients with aneurysmal dilatation/aneurysm of the descending aorta and/or peripheral arteries confirmed by ultrasonography and/or computed tomography angiography (CTA).

5\. Elevated acute phase reactants ESR and hs-CRP.

Exclusion Criteria:

1. Cardiovascular manifestations that cannot be distinguished from giant cell arteritis, Burger's disease, or atherosclerotic aneurysm; infectious aneurysm;
2. Other active organ involvement related to BS that requires intensified immunosuppressive treatment, including gastrointestinal ulcers, uveitis, and parenchymal neurological involvement;
3. Patients with severe aneurysms requiring emergency intervention surgery; patients with elective surgery indications require the consensus between rheumatologists and vascular surgeons to determine inclusion or exclusion.
4. Severe organ dysfunction, including ALT, AST, and TBIL exceeding the upper limit of normal by more than 2 times, serum creatinine ≥ 133 mmol/L, white blood cell count \< 3×10\^9/L, ANC \< 2×10\^9/L, hemoglobin \< 80g/L, platelet count \< 100×10\^9/L;
5. Active infection such as active tuberculosis, hepatitis B or C, syphilis, chronic EBV infection, persistent or severe bacterial or viral infection;
6. Primary or secondary immunodeficiency;
7. Malignant tumor;
8. Use of immunosuppressants such as Cyclosporin A (CsA), Azathioprine (AZA), Tacrolimus (TAC), Mycophenolate Mofetil (MMF), or Cyclophosphamide (CTX) within 1 month;
9. Use of biologics/small molecule drugs within 5 half-lives (baricitinib within 10 days; etanercept within 4 weeks; infliximab within 8 weeks; adalimumab, golimumab, ustekinumab, and abatacept within 10 weeks, secukinumab within 6 months, and previously use of tocilizumab and tofacitinib);
10. Pregnant, lactating, or planning a recent pregnancy;
11. Subjects who do not agree to or are unable to comply with regular visits.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jinjing Liu, M.D.
• Email: wingsforjane@163.com
• Phone: 8613581605769

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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.