EUCTR2014-000488-42-NL进行中（未招募）1 期
The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - SynBiose
eiden University Medical Center0 个研究点目标入组 15 人开始时间: 2014年5月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •4.1. Inclusion criteria
- •Subjects enrolled in the study must meet the following inclusion criteria:
- •1) age 18 years,
- •2) ACR diagnosis of SLE (1997 revised criteria, see appendix 1)
- •3) Severe SLE flare at screening (see also section 5.2.3.2.), defined as a situation in which 1 or more of the following criteria are met:
- •- Increase in SLEDAI (SLE Disease Activity Index) with 12 or more points
- •- New or worse SLE-related activity of major organs, i.e.: CNS-SLE (includes NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis, trombocytopenia < 60, hemolytic anemia < 4.4mmol/L (=7.0g/dL).
- •4) Refractory disease, defined as persisting or progressive disease activity (SLEDAI > 6 points) despite conventional immunosuppressive treatment and 1 or more of the following criteria:
- •- failure of the initial induction treatment at six months, for which a switch to another induction therapy regime has already been carried out;
- •- intolerance or contraindication for cyclophosphamide and mycophenolate mofetil (MMF);
- •- exceeding a cumulative dose of 15 gram of cyclophosphamide;
- •- a second relapse within two years after start of the initial induction therapy
- •- a relative contraindication for high-dose oral or intravenous (iv) prednisone, such as avascular osteonecrosis, previous psychosis on corticosteroids, osteoporosis and/or severe obesity (BMI =35 kg/m2).
- •5) ANA seropositivity, as defined by a positive ANA-titer = 1:80, before and at screening :
- •- Positive test results from 2 independent time points within the study screening period; OR
- •- One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of ANA (eg, ANA by HEp-2 titer, ANA by ELISA) must include the date of the test.
- •6) Anti-DNA seropositivity, as defined by a positive anti-dsDNA serum antibody = 30 IU/mL, before and at screening:
- •- Positive test results from 2 independent time points within the study screening period.
- •- One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of anti-dsDNA (eg, anti-dsDNA by Farr assay or ELISA) must include the date of the test.
- •7) Immune-complex mediated complement usage, as defined by:
- •- a low C3 serum level = 0.9 g/L; OR
- •- a low C4 serum level = 95 mg/L; OR
- •- a reduced activation of the classical pathway < 75%
- •8) Use of effective contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from participation if they meet any of the following exclusion criteria:
- •1) Active pregnancy, as proven by a positive urine beta-HCG test or a positive serum beta-HCG
- •2) Significant B-cell depletion (peripheral B-cell counts < 60x10E6)
- •3) Significant hypogammaglobulinemia (IgG < 8.0 g/L)
- •4) Immunization with a live vaccine 1 month before screening
- •5) Active infection at time of screening, as follows:
- •- Hospitalization for treatment of infection within previous 2 months 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 2 months of day 0 of the study
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