EUCTR2006-003836-31-BE进行中（未招募）不适用
A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab
niversity Hospital Gent0 个研究点开始时间: 2006年8月2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
- •Female/male >, = 18 years
- •SSc according to the ARA criteria for systemic sclerosis
- •Disease duration less than 4 years (from the appearance of skin changes (oedema, fibrosis)
- •Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated
- •Antibodies specific for systemic sclerosis: anti-topoisomerase; anti-centromere antibodies
- •Severe disease defined by either one of the following:
- •o A modified Rodnan skin score (TSS° >,= 14 )
- •o Disease activity score >,= 3
- •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) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease duration more than 4 years
- •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.
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