EUCTR2009-012034-70-BE进行中（未招募）不适用
A protocol based treatment for debilitating fibrosing skin disorders with (anti-CD-20), rituximab
niversity Hospital Ghent0 个研究点开始时间: 2009年4月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •(Fe) male >, = 18 years
- •Fibrosing skin disorder, not fulfilling the ACR criteria for diffuse SSc
- •Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated
- •Debilitating disease defined by either one of the following:
- •oRestriction of mobility
- •oDisfiguration: eg: facial involvement
- •oSevere Internal Organ involvement
- •Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.
- •Patient has signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •FVC<, = 50%
- •LVEF<, = 40% of predicted value,
- •DLCO<, = 40% of predicted value
- •Exclusion criteria as specifically described in the protocol for anti-CD-20:
- •-Lack of peripheral venous access.
- •-Pregnancy or breast feeding.
- •-Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
- •-Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator’s opinion, would preclude patient participation.
- •-Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
- •-Known active infection of any kind (excluding fungal infections of mail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline.
- •-History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks prior to baseline.
- •-History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening).
- •-History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
- •-History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of rituximab or to murine proteins.
- •-Concurrent treatment with any biologic agent or DMARD other than MTX. Treatment must be discontinued 14 days prior to baseline , except for the following: azathioprine for = 28 days; leflunomide for = 8 weeks (or = 14 days after 11 days of standard cholestyramine or activated charcoal washout); infliximab = 8 weeks; adalimumab = weeks.
- •-Previous treatment with > 1 biological agent.
- •-Previous treatment with any cell depleting therapies, including investigational agents.
- •-Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (xhich ever is the longer).
- •-Receipt of any vaccine within 28 days prior to baseline
- •-Intolerance or contraindications to i.v. glucocorticoids.
- •-Positive serum human chorionic gonadotropin (hCG) measured at screening or a positive pregnancy test prior to the first rituximab infusion.
- •-Positive tests for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology.
- •-Hemoglobin < 8.0 g/dL.
- •-Concentrations of serum IgG and/or IgM below 5.0 and 0.40 mg/mL, respectively.
- •-Absolute neutrophil count (ANC) < 1.5 X 10³/µL.
研究者
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