NL-OMON49246招募中3 期
Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial. - IVIG in myositis: TIME IS MUSCLE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 48
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
- •Adult patients (18-80 years) with idiopathic inflammatory myopathy (IIM),
- •according to diagnostic criteria:
- •- Dermatomyositis
- •- Non-specific/overlap myositis including antisynthetase syndrome; formerly
- •known as polymyositis
- •- Immune mediated necrotizing myopathy
- •Disease duration; 12 months
- •Signed informed consent
排除标准
- •Disease duration > 12 months
- •Immunosuppressive medication within the last 12 months (azathioprine,
- •methotrexate plasmapheresis, IVIg, biologicals). We will allow prednisone dosed
- •as follows:
- •- Daily dose 20 mg or lower, used for two weeks or less
- •- Daily dose higher than 20 mg, used for 1 week or less
- •- No evident clinical response
- •Related to IVIG:
- •- History of thrombotic episodes within 10 years prior to enrolment
- •- Known allergic reactions or other severe reactions to any blood-derived
- •- Known IgA deficiency and IgA serum antibodies
- •- Pregnancy (wish)
- •Conditions that are likely to interfere with:
- •- Compliance (legal incompetent and/or incapacitated patients are excluded),
- •- Evaluation of efficacy (e.g. due to severe pre-existing disability as a
- •result of any other disease than myositis or due to language barrier)
研究者
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