A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- • Disease activity index
研究概览
简要总结
Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality.
The treatment back-bone is based on prednisolone administration. There are controversies on the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid sparing drugs. For others, they are disease modifying drugs.
The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.
详细描述
The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.
Official Title: Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Azathioprine in New Cases of Pemphigus Vulgaris Receiving Prednisolone
Randomized Double Blind Controlled Trial of Azathioprine versus Placebo in new cases of Pemphigus Vulgaris treated with Prednisolone
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Controlled, Parallel Assignment, Safety/Efficacy Study
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lesions clinically consistent with pemphigus vulgaris
- •Diagnosis confirmed by histology in terms of acantholysis within past month
- •Positive DIF
排除标准
- •Any nursing or pregnant woman
- •Any history of chronic diseases including liver disease, Chronic Renal Failure, Chronic Heart Failure or Ischemic Heart Disease
- •Present diagnosis of hepatitis confirmed by serology or elevated hepatic enzymes;
- •Clinically significant concurrent medical disease or laboratory abnormalities evidenced by one or more of the following:
- •Hepatobiliary AST or ALT ≥ 1.5 × upper limit of normal (ULN);alkaline phosphatase ≥ 1.5 × ULN; or, total bilirubin > 90% of the ULN;
- •Renal serum creatinine > 1.5 mg/dL; or, significant proteinuria > 2+ on urinary dip test;
- •Hematologic hemoglobin < 11 mg/dL; leukocytes < 3.5 × 109/L; neutrophils < 1.5 × 109/L; or, platelets < 100 × 109/L; Presence of anemia, leukopenia or thrombocytopenia
- •Any sign of patient's non-compliance
- •Known hypersensitivity to study drugs, prednisone or azathioprine
- •Participating in another clinical trial at the time of screening and enrollment
研究组 & 干预措施
1
Oral administration of prednisone and azathioprine throughout study
干预措施: Azathioprine (Drug)
1
Oral administration of prednisone and azathioprine throughout study
干预措施: Prednisone (Drug)
2
Oral administration of prednisone and placebo throughout study
干预措施: Prednisone (Drug)
2
Oral administration of prednisone and placebo throughout study
干预措施: Placebo (Drug)
结局指标
主要结局
• Disease activity index
时间窗: Throughout study; first two weeks every day, then weekly for two weeks, then monthly for eleven months
次要结局
- Total dose of corticosteroid(At the end of study)
- Occurence of any adverse event(Throughout study)
- Occurence of Grade 3 or higher treatment-related adverse event(Throughout study)
- Adverse events resulting in discontinuation and assessed by the investigators as at least possibly related to treatment(Throughout study)