Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment
研究概览
简要总结
Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients.
The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease, control trials are difficult to conduct. Evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against B- lymphocytes) or immunoadsorbtion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >=18 and <= 80years
- •consent obtained from patient
- •effective female contraceptive method for women in procreate age
- •new case of pemphigus vulgaris (PV) or pemphigus foliaceus (PF)
排除标准
- •pemphigus vulgaris (PV) or pemphigus foliaceus (PF) treated
- •pregnant woman or nursing mother
- •woman able to have a baby and without contraception during the clinical trial period
- •age < 18 or > 80
- •karnovsky < 50%
- •serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
- •patient with depletion lymphocytic treatment in the next month
- •unstable angina or ischemic heart disease
- •cardiac insufficiency
- •cardiac rhythm trouble uncontrolled
- •positive HIV serology
- •positive hepatitis B and / or C serology
- •no consent
研究组 & 干预措施
Rituximab
干预措施: Rituximab (Drug)
Corticotherapy
General Corticotherapy
干预措施: General Corticotherapy (Drug)
结局指标
主要结局
Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment
时间窗: 2 years
次要结局
- Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment(6 months)
