JPRN-UMIN000030139已完成2 期
Double-Blind, parallel-group comparison, investigators initiated phase II clinical trial of IDEC-C2B8 (Rituximab) in patients with Systemic Sclerosis - "D"oubl"e"-Blind, parallel-group compari"s"on, "i"nvestigators initiated phase II clinical trial of IDEC-C2B8 ("R"ituximab) in pati"e"nts with "S"ystemic sclerosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
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
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Patients who have pulmonary hypertension with SSc >The echocardiography is performed during the pretreatment period in order to confirm the complication of pulmonary hypertension. A diagnosis of the specialty department such as cardiovascular department is carried out when the pulmonary artery systolic pressure by the Doppler ultrasonography is more than 35mm Hg. 2)Patients who have serious complications (the renal crisis) other than interstitial pneumonia >With regard to interstitial pneumonia, patients who meet with the following 3) criterion will be excluded. 3)Patients who were judged that there was not enough spare ability (Less than 60%VC or less than 40%DLco calculated by newly generated prediction equation for Japanese) 4)Patients who are proved to have an HIV antibody 5)Patients that the positivity was confirmed in more than one of the HBs antigen, the HBs antibody, the HBc and HCV antibodies 6)Have serious bacterial/fungal infections 7)Have serious lung disorder 8)Have serious kidney diseases 9)Have severe heart disease 10)Have active tuberculosis 11)Have the merger of the malignant tumor, or who have the history within past 5 years 12)Have the previous history of significant infection 13)With an ingredient of this agent or serious erethism for the product derived from mouse protein or the anamnesis of the anaphylactic reaction 14)Women who are pregnant, breast feeding or positive of pregnant test 15)Patients who do not attempt to do contraception during the study period (until at least 12 months after the study end) 16)Have the disease, body condition and mental condition which make the study enforcement more difficult 17)Were administered the other investigational product within 12 weeks of the entry, or Patients who are participating in the other clinical study 18)Smoked within 12 weeks before the informed consent 19)Other patients who were judged ineligible by the study investigator
研究者
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