NCT00363350已完成1 期
Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- stimulated whole salivary flow rate
研究概览
简要总结
This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.
详细描述
Study design:
phase II trial
Study objective:
evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS
Number of participating centres:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stimulated whole saliva secretion ≥ 0,15 ml/min
- •Male or female > 18 years
- •Primary SS according to the revised European - U.S. criteria(22)
- •Positive autoantibodies (IgM-Rf > 10 and SS-A and/or SS-B)
- •Parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago)
- •Use of reliable method of contraception during the study
- •Written informed consent
排除标准
- •The presence of any other connective tissue disease
- •Preceding treatment with anti-TNF or other monoclonal antibodies
- •Use of prednisone, hydroxychloroquine less than 1 month ago
- •Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago
- •Serum creatine > 2.8 mg/dl (250 micromol/l)
- •ASAT or ALAT outside 1.5 x upper normal range of the laboratory
- •Hb < 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
- •Neutrophil granulocytes less than 0.5 x 109/l
- •Platelet count less then 50 x 109/l
- •Positive pregnancy test or breast-feeding
- •History of alcohol or drug abuse
- •Serious infections
- •Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study
- •History of any malignancy with the exception of completely resected basal cell carcinoma of the skin
结局指标
主要结局
stimulated whole salivary flow rate
时间窗: 48 weeks
次要结局
- Functional parameters(48 weeks)
- Laboratory parameters(48 weeks)
- Subjective parameters(48 weeks)
- Histological/Molecular parameters(12 weeks)
研究者
研究点 (2)
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