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临床试验/NCT00784589
NCT00784589已完成3 期

Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Rituximab (Drug)

Corticotherapy

Active Comparator

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)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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