Lenalidomide in the Treatment of Mucosal Behçet's Syndrome
Trial Parameters
Brief Summary
The study is to evaluate the efficacy and safety of lenalidomide in the treatment of oral ulcers in adult patients with refractory mucosal Behcet's syndrome.
Eligibility Criteria
Inclusion Criteria: * Patients that can understand and voluntarily sign an informed consent document prior to the study; * Male and female subjects ≥ 18 years and ≤ 65 years of age at the time of signing the informed consent document. * Fulfilling the ICBD (International Conference on Behcet's Disease) criteria(2013); * Presented with active mucosal lesions: Subjects must have at least 1 oral ulcer within 4 weeks after the screening visit and at least 2 oral ulcers on the day of enrollment; subjects may be with or without genital ulcers and (or) skin lesions. * Refractory mucosal lesions: Subjects must experience at least 2 relapses of oral ulcers during 3 consecutive months of conventional treatment with corticosteroids and(or) immunosuppressants. * Without major organ involvement, including active gastrointestinal, ocular, nervous system, and major vessel involvement; previous major organ involvement is allowed if it occurred at least 1 year prior to the screening visit and is not ac