NL-OMON42194已完成2 期
The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - Synergetic B-cell immunomodulation in SLE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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, thrombocytopenia < 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) Female subjects are eligible to enter the study if she is:
- •- Not pregnant or nursing
- •- Of non-child-bearing potential (i.e. after hyseterectomy, postmenopausal, bilateral ovariectomy or documented bilateral tubal ligation or other permanent female sterilization procedure)
- •- Use of effective contraception:
- •* Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception); OR
- •* Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent, during the study, and 16 weeks after the last dose of study agent:
- •o Oral contraceptive, either combined or progestogen alone
- •o Injectable progestogen <
排除标准
- •4.2. Exclusion criteria
- •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 < 4.0 g/L) or an IgA deficiency (IgA < 0.1 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
- •- Serological evidence of active viral hepatitis defined as: patients positive for HbsAg test or HBcAb or a positive hepatisits C antibody
- •6) Have a historically positive HIV test or test positive at screening for HIV
- •7) Have a history of a primary immunodeficiency
- •8) Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
- •9) Have any other clinically significant abnormal laboratory value in the opinion of the investigator
- •10) Have current drugs or alcohol abuse or dependence
- •11) Have an active malignant neoplasm or one in the history of the last 5 years
- •12) Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who, in the investigator*s opinion, pose a significant suicide risk
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