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Short-Term Relapse Quantitation as a Fully Surrogate Endpoint for Long-Term Sustained Progression of Disability in RRMS Patients Treated with Natalizumab
المؤلفون المشاركون
Miao, X.
Sandrock, A.
Richert, J. R.
Meyerson, L.
Wang, Y. C.
المصدر
Neurology Research International
العدد
المجلد 2011، العدد 2011 (31 ديسمبر/كانون الأول 2011)، ص ص. 1-6، 6ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2011-12-26
دولة النشر
مصر
عدد الصفحات
6
التخصصات الرئيسية
الملخص EN
Time to sustained worsening in the expanded disability status scale as the standard for evaluating the accumulation of disability has been used as a measure of clinical efficacy in many relapsing-remitting multiple sclerosis (RRMS) clinical trials.
However, this measurement usually requires a large sample and long-term study to demonstrate the treatment effect.
Annualized relapse rate or time to first relapse is also widely used as alternative measurements of clinical efficacy.
A formal statistical validation of short-term relapse activity as a surrogate endpoint for long-term sustained progression of disability could potentially permit smaller, shorter, and less expensive clinical trials in RRMS.
Four statistical validation/evaluation approaches consistently showed that relapse activity through one year of treatment serves as statistically valid surrogate endpoint for time to sustained progression of disability.
The analysis demonstrates that long-term sustained progression of disability can be predicted by short-term relapse measures with 4 consistent validations of statistical approaches, including a formal statistical hypothesis test.
This was demonstrated in a large phase III trial of natalizumab and showed that the beneficial clinical effect of natalizumab on sustained progression of disability at 2 years in patients with RRMS can be predicted by the total number of relapses at 1 year.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Wang, Y. C.& Sandrock, A.& Richert, J. R.& Meyerson, L.& Miao, X.. 2011. Short-Term Relapse Quantitation as a Fully Surrogate Endpoint for Long-Term Sustained Progression of Disability in RRMS Patients Treated with Natalizumab. Neurology Research International،Vol. 2011, no. 2011, pp.1-6.
https://search.emarefa.net/detail/BIM-453634
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Wang, Y. C.…[et al.]. Short-Term Relapse Quantitation as a Fully Surrogate Endpoint for Long-Term Sustained Progression of Disability in RRMS Patients Treated with Natalizumab. Neurology Research International No. 2011 (2011), pp.1-6.
https://search.emarefa.net/detail/BIM-453634
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Wang, Y. C.& Sandrock, A.& Richert, J. R.& Meyerson, L.& Miao, X.. Short-Term Relapse Quantitation as a Fully Surrogate Endpoint for Long-Term Sustained Progression of Disability in RRMS Patients Treated with Natalizumab. Neurology Research International. 2011. Vol. 2011, no. 2011, pp.1-6.
https://search.emarefa.net/detail/BIM-453634
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-453634
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
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