PILOT STUDY OF TOL, TOX & EFF OF BETA INTERFERON IN INCLUSION BODY MY

TOL、TOX 的试点研究

• 批准号: 6303814
• 负责人: RABI TAWIL
• 金额: $ 1.48万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6303814
• 关键词: clinical research; clinical trial phase I; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; interferon beta; muscle disorder chemotherapy; myositis

Inclusion Body Myositis is an inflammatory myopathy whose precise pathogenesis is unknown. It has not effective treatment. This study hypothesizes that immune-mediated muscle damage is of primary or secondary importance in producing the muscle weakness and wasting that characterizes IBM. Although corticosteroids and other immune suppressant medications may be of minor benefit in some patients, they are generally effective. Immunomodulating agents, notably the interferons, appear to hold promise in a number of inflammatory diseases. Beta interferon has been approved for use in multiple sclerosis, a disease with features suggesting a still-undefined immune pathogenesis and for which corticosteroids are of limited benefit. This study will investigate the tolerability and safety of intramuscular Beta interferon and will indentify problems with and refine the various muscle testing procedures to optimize their usefulness as primary outcome measures.

包涵体肌炎是一种炎症性肌病，其确切的发病机制尚不清楚。 目前尚无有效的治疗方法。 这项研究假设，免疫介导的肌肉损伤是主要或次要的重要性，在产生肌肉无力和浪费的特点IBM。 虽然皮质类固醇和其他免疫抑制药物可能对某些患者的益处不大，但它们通常是有效的。 免疫调节剂，特别是干扰素，似乎在许多炎症性疾病中有希望。 β-干扰素已被批准用于多发性硬化症，这种疾病的特征表明免疫发病机制尚未明确，皮质类固醇的益处有限。这项研究将调查肌肉注射β干扰素的耐受性和安全性，并将确定问题和完善各种肌肉测试程序，以优化其作为主要结局指标的有用性。