NL-OMON32498尚未招募2 期
Anti-CD20 for the retreatment of primary Sjögren*s syndrome in patients who were included in the placebo-controlled double blinded rituximab study - Anti-CD20 for retreatment in primary Sjögren*s syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Stimulated whole saliva secretion >= 0,15 ml/min
- •* Male or female of 18 years or older
- •* 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 (paraffin material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 24 months ago)
- •* Use of reliable method of contraception during the first 48 weeks of 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 than rituximab
- •* Use of prednisone, hydroxychloroquine less than 1 month ago
- •* Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than * year ago
- •* Serum creatine > 2.8 mg/dl (250 *mol/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
研究者
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