EUCTR2021-000009-25-FR进行中（未招募）1 期
Rituximab therapy in anti-MAG patients with characteristics of good responders: THERAMAG study - THERAMAG
CHU SAINT-ETIENNE0 个研究点目标入组 90 人开始时间: 2021年2月2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
- 90
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
- •-Age over 18
- •-Disease duration of 24 months or less and documented clinical worsening (clinical or ENMG or disability) over the past 12 months
- •-IgM gammopathy, either MGUS or WM
- •-Demyelinating polyneuropathy according to European Federation of Neurological Societies/Peripheral Nerve Society guidelines for chronic inflammatory demyelinating polyneuropathy on nerve conduction studies.
- •-Anti-MAG titre of 10 000 BTU or more
- •-Total INCAT score of 1 point or more at baseline
- •-Absence of immunoglobulin treatment within 3 months prior to inclusion.
- •-Absence of immunosuppressive therapy within 6 months prior to inclusion, including steroid therapy of 2 months or more as part of the management of neuropathy.
- •-Negative ß-HCG in women of childbearing potential.
- •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 45
排除标准
- •-Unable to give informed consent
- •-History of severe allergic or anaphylactic reaction to chimeric monoclonal antibody
- •-Previous treatment with rituximab
- •-Diseases known to cause polyneuropathy (e.g. diabetes, uncontrolled thyroid disease, vitamin B1 or B12 deficiency, renal (GFR < 60ml ml/min/1,73 m2- MDRD formula) or liver disorder, myeloma, amyloidosis, cryoglobulinemia)
- •-Indication of specific immunosuppressive therapy for WM
- •-Significant uncontrolled disease at baseline such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal or any other significant disease that may prevent patient from participating in the study
- •-Congestive heart failure (NYHA III or IV)
- •-Known active bacterial, viral, fungal mycobacterial infection
- •-History or known presence of recurrent or chronic infection (e.g. viral hepatitis, HIV syphilis, tuberculosis).
- •-History of cancer, including solid tumors and haematological malignancies (except basal cell and in situ squamous carcinoma of the skin, in situ carcinoma of the cervix of the uterus that have been excised and resolved, with documented clear margins on pathology)
- •-History of alcohol (more than two drinks a day for a woman, more than 4 glasses a day for a man [(WHO definition])) or other drug abuse within 6 months prior to randomization
- •-History or currently active primary or secondary immunodeficiency
- •-White blood cell count < 1500/mm3 or platelet count < 75 000/mm3
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