NL-OMON21172招募中不适用
Evaluating favorable, immunological effects of rituximab with cyclophosphamide compared to rituximab alone in AAV patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MC
- 入组人数
- 47
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
入选标准
- •4.1. Inclusion criteria
- •Subjects enrolled in the study must meet the following inclusion criteria:
- •1) Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic Polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions26
- •2) Aged at least 18 years, with newly-diagnosed or relapsed AAV with ‘generalised disease’, defined as involvement of at least one major organ (e.g. kidney, lung, heart, peripheral or central nervous system), requiring induction treatment with cyclophosphamide or rituximab
- •3) Positive test for anti-PR3 or anti-MPO (current or historic)
- •4) Willing and able to give written Informed Consent and to comply with the requirements of
- •the study protocol
排除标准
- •4.2. Exclusion criteria
- •Subjects will be excluded from participation if they meet any of the following exclusion criteria:
- •1) Pregnant or breast-feeding
- •2) Active pregnancy, as proven by a positive urine beta-HCG test or a positive serum beta-HCG
- •3) Significant hypogammaglobulinemia (IgG < 4.0 g/L) or an IgA deficiency (IgA < 0.1 g/L)
- •5) Active infection at time of screening, as follows:
- •-Hospitalization for treatment of infection within previous 60 days of day 0 of the study
- •-Use of parenteral (intravenous of intramuscular) antibiotics (including anti-bacterials, anti-virals, anti-fungals or anti-parasitic agents) within previous 60 days of day 0 of the study
- •-Serological evidence of viral hepatitis defined as: patients positive for HbsAg
- •test or HBcAb or a positive hepatitis C antibody not treated with antiviral medication
- •-Have a historically positive HIV test or test positive at screening for HIV
- •6) Have a history of a primary immunodeficiency
- •7) Have a significant infection history that in the opinion of the investigator would make the candidate unsuitable for the study
- •8) Have a neutrophil count of < 1.5x10E9/L
- •9) Evidence of hepatic disease: AST, ALT, alkaline phosphatase, or bilirubin > 3 times the upper limit of normal before start of dosing
- •11) Have any other clinically significant abnormal laboratory value in the opinion of the investigator
- •12) Required dialysis or plasma exchange within 12 weeks prior to screening
- •13) Received intravenous glucocorticoids, >3000mg methylprednisolone equivalent, within 4 weeks prior to screening
- •14) Immunization with a live vaccine 1 month before screening
- •15) History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the patient at unacceptable risk for study participation.
- •16) Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
研究者
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