CLINICAL TRIAL: BETASERON/BETAFERON IN MS

临床试验：BETASERON/BETAFERON 在 MS 中的应用

• 批准号: 7718677
• 负责人: MICHAEL K RACKE
• 金额: $ 0.17万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718677
• 关键词: Adverse effects; Benefits and Risks; Caring; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Funding; Grant; Institution; Interferon-beta; Laboratories; Medical; Patients; Pharmaceutical Preparations; Phase; Physical Examination; Population; Recombinant interferon beta-1b; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The BEYOND FOLLOW-UP study will give patients taking part in the BEYOND study the opportunity to continue treatment with the interferon beta 1b high dose (500 'b5g) and will further investigate the safety and tolerability profile of interferon beta 1b 500 ug during long term treatment. This study will investigate expected side effects as well as unexpected side effects of the new, high dose of interferon beta 1b (500 ug) that might only be seen if medication is administered longer and in a larger patient population. As the risk-benefit ratio of the 500 ug dose will only be known after results of the BEYOND study will have been evaluated; in Phase A, every patient who has not yet been treated with the 500 ¿g dose during the preceding BEYOND trial will only receive treatment with the 250 ug dose of interferon beta-1b. All patients in the BEYOND FOLLOW-UP study will be given active treatment. It can be reasonably assumed that treatment with the 500 ¿g dose of interferon beta-1b is as least as effective as treatment with the currently approved dose (250 ¿g). In addition, you may also benefit from the extra medical care which will be part of the study including general physical examinations and laboratory checks.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 BEYOND随访研究将为参与BEYOND研究的患者提供继续接受干扰素β 1b高剂量（500 μ g）治疗的机会，并将进一步研究干扰素β 1b 500 μ g在长期治疗期间的安全性和耐受性特征。 这项研究将调查预期的副作用以及新的，高剂量的干扰素β 1b（500 μ g）的意外副作用，只有在更长的时间和更大的患者人群中使用药物时才可能看到。 由于500 μ g剂量的风险-获益比只有在BEYOND研究结果评估后才能得知;在A期，在之前的BEYOND试验中尚未接受500 μ g剂量治疗的每位患者将仅接受250 μ g剂量的干扰素β-1b治疗。BEYOND FOLLOW-UP研究中的所有患者都将接受活性治疗。 可以合理地假设，500 μ g剂量的干扰素β-1b治疗与目前批准的剂量（250 μ g）治疗一样有效。 此外，您还可能受益于额外的医疗护理，这将是研究的一部分，包括一般体格检查和实验室检查。