A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel Group, Mult-center, 52-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Percentage of Patients Achieving Responder Status at Week 52
研究概览
简要总结
This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to treatment. The anticipated time on study treatment was 12 months, and the target sample size was <100 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18 to 70 years of age
- •Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids
排除标准
- •Female patients who are pregnant, breastfeeding, or lactating
- •Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization
- •CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization
- •Use of PV therapies other than those noted above, within 4 weeks prior to randomization
- •Use of topical corticosteroids within 2 weeks prior to randomization
研究组 & 干预措施
Mycophenolate Mofetil (MMF) 2 g/Day
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
干预措施: Mycophenolate Mofetil 2 g/Day (Drug)
Mycophenolate Mofetil (MMF) 3 g/Day
Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
干预措施: Mycophenolate Mofetil (MMF) 3 g/Day (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients Achieving Responder Status at Week 52
时间窗: 52 weeks
The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group
次要结局
- Time to Initial Response(up to 52 weeks)
- Time to Sustained Response(up to 52 weeks)
- Duration of Prednisone Maintenance Dosing(52 weeks)