EUCTR2011-000899-33-SE进行中（未招募）不适用
Rituximab (RTX) therapy in steroid resistant patients or patients relapsing after intravenous steroids with active TAORescue RTX - rescue RTX
Department of Endocrinology, Sahlgrenska University Hospital0 个研究点目标入组 50 人开始时间: 2011年6月13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
- 入组人数
- 50
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
- •Inclusion criteria
- •Man or woman between 18-70 years.
- •TAO with CAS of = 4 (less than 3 months).
- •Euthyroid for at least 6 weeks
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Exclusion criteria
- •Dysthyroid optic neuropathy (DON)
- •Ulcerative Keratitis
- •Previous treatment with steroids for TAO (do not include prophylaxis for TAO in connection with radio iodine treatment)
- •Previous Treatment with Rituximab (MabThera®)
- •Positive Hepatitis B or C serology.
- •Receipt of a live vaccine within 4 weeks prior RTX+MTX to randomization
- •History of recurrent significant infection or history of recurrent bacterial infections
- •Patient who may not attend to the protocol according to the investigators opinion.
- •Pregnancy or lactation
- •Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease).
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •Concomitant malignancies or previous malignancies.
- •Previous active tuberculosis
- •Alkoholism
- •Alkoholic related liver disease or other chronical liver disease
- •Bone marrow depression with leukopenia, thrombocytopenia or significant anemia
- •Reumatoid or other significant pulmonary disease
- •Allergy to the active substance or any other substance in the medications or murine proteins
- •Active, severe infections (such as tuberculosis, sepsis or opportunistic infections)
- •Patients with severe immunosuppression
- •Severe cardiac failure or severe uncontrolled heart disease
研究者
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