Withdrawal of Colchicine in Behçet Syndrome Patients With Skin and Mucosa Involvement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 主要终点
- Number of oral ulcers
研究概览
简要总结
Behçet's syndrome is a multisystem variable vessel vasculitis. Clinical features include mucocutaneous manifestions such as oral ulcers, genital ulcers, papulopustular lesions and nodular lesions, musculoskeletal manifestations, uveitis, venous thrombosis, arterial aneurysms and thrombosis, central nervous system involvement and gastrointestinal involvement. Management of Behçet's syndrome depends on the type of organ involvement, disease severity, and prognostic factors. The main objective in patients with major organ involvement is to rapidly suppress the inflammation and prevent relapses in order to prevent organ damage. On the other hand, mucocutaneous and musculoskeletal manifestations do not cause damage and in patients with only mucocutaneous and joint involvement, the aim is to improve the quality of life.
Colchicine is usually the first-line systemic treatment in patients with only mucocutaneous and joint involvement. Conflicting results were reported on the efficacy of colchicine on different mucocutaneous manifestations in randomized placebo-controlled trials. The relapsing and remitting nature of these manifestations in Behçet's syndrome may cause challenges in disease assessment during clinical trials. Another approach to evaluate the effectiveness of a medication is to evaluate whether the lesions recur or increase after discontinuation of the drug. The aim of this study is to assess mucocutaneous disease activity among Behçet's syndrome patients after discontinuation of colchicine treatment and compare it to patients who continue to use colchicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling International Study Group criteria. Being between the ages of 18 and 65 years. Having mucocutaneous involvement. Using colchicine at a stable dose (1-2 mg/day) for at least 3 months. Showing no adverse events related to colchicine use. Providing informed consent to participate in the study. -
排除标准
- •Patients with active uveitis. Patients with active venous involvement. Patients with active arterial involvement. Patients with active nervous system involvement. Patients with active gastrointestinal involvement.
研究组 & 干预措施
Colchicine
干预措施: Colchicine (Drug)
结局指标
主要结局
Number of oral ulcers
时间窗: 4 weeks
次要结局
- Pain of genital ulcers(4 weeks)
- Pain of nodular lesions(4 weeks)
- Number of papulopustular lesions(4 weeks)
- Number of genital ulcers(4 weeks)
- Number of nodular lesions(4 weeks)
- Pain of oral ulcers(4 weeks)
- Swollen joint count(4 weeks)
- Tender joint count(4 weeks)
- Health related quality of life(4 weeks)
- New organ involvement(4 weeks)
- Overall disease activity(4 weeks)
研究者
Gulen Hatemi
Professor
Istanbul University - Cerrahpasa (IUC)
