Clinical and immunological factors predicting relapse in patients with pemphigustreated with rituximab: A prospective cohort study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 2. Comparison of changing trends of CD 19+ and CD19+27+ B cells between relapsing and non-relapsing patients.
研究概览
简要总结
Pemphigus is a potentially life-threatening autoimmune blistering disease. Treatment modalities include systemic corticosteroids, immunosuppressive agents (cyclophosphamide, azathioprine, mycophenolate mofetil etc) and rituximab (anti-CD20 monoclonal antibody). Rituximab is now recommended as one of the first-line treatments of pemphigus. However, relapses are common with all these therapies. Relapse rates with rituximab have been estimated at 2%, 14% and 40% at 6 months, 12 months and overall, respectively. The time to relapse after treatment with rituximab ranges from 6-24 months. Maintenance doses of rituximab, if can be given before the clinical relapse, can help prolong the disease-free remission period. Identification of factors that may predict the relapse can guide early intervention, the timing of maintenance dose, and decrease morbidity. There are only a few previous studies on this subject area, and have shown largely conflicting results. Our study aims to identify the clinical and immunological factors predicting relapse in patients with pemphigus treated with rituximab.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed pemphigus vulgaris or foliaceus treated with RTX- RA protocol.
排除标准
- •Patients who have received RTX cycles in the preceding one year.
- •Patients with other concomitant autoimmune diseases.
- •Pregnant and lactating patients.
- •Patients who cannot come for follow up visits for at least 18 months.
结局指标
主要结局
2. Comparison of changing trends of CD 19+ and CD19+27+ B cells between relapsing and non-relapsing patients.
时间窗: Baseline, 3, 6, 9, 12 months
1. Comparison of the changing trends of anti-dsg1, anti-dsg3, and anti-AchR (M3) antibody values between patients who relapse and who do not relapse.
时间窗: Baseline, 3, 6, 9, 12 months
3. Comparison of baseline clinical parameters between relapsing and non-relapsing during the first two years after the initial cycle of rituximab.
时间窗: Baseline, 3, 6, 9, 12 months
次要结局
- 1. Comparison of baseline immunological and clinical parameters between patients who experience disease flare and those who do not at the end of first month.