کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
3285298 | 1209225 | 2007 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A Randomized, Double-Masked, Placebo-Controlled Study of Alicaforsen, an Antisense Inhibitor of Intercellular Adhesion Molecule 1, for the Treatment of Subjects With Active Crohn's Disease
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کلمات کلیدی
ICAM-1CRMCDAITNFAUC - AUCclinical remission - رمی بالینیCrohn’s Disease Activity Index - شاخص فعالیت بیماری کرونtumor necrosis factor. - عامل نکروز تومورarea under the curve - منطقه تحت منحنیIntercellular adhesion molecule 1 - مولکول چسبندگی بین سلولی 1C-reactive protein - پروتئین واکنشی سیCRP - پروتئین واکنشی سی یا سی. آر. پی
موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
بیماریهای گوارشی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: A Randomized, Double-Masked, Placebo-Controlled Study of Alicaforsen, an Antisense Inhibitor of Intercellular Adhesion Molecule 1, for the Treatment of Subjects With Active Crohn's Disease A Randomized, Double-Masked, Placebo-Controlled Study of Alicaforsen, an Antisense Inhibitor of Intercellular Adhesion Molecule 1, for the Treatment of Subjects With Active Crohn's Disease](/preview/png/3285298.png)
چکیده انگلیسی
Background & Aims: The aim of this study was to compare the safety and efficacy of alicaforsen, a first-generation antisense inhibitor of intercellular adhesion molecule 1, with placebo in subjects with active Crohn's disease, a disorder in which intercellular adhesion molecule 1 is overexpressed. Methods: In 2 identical double-masked, placebo-controlled studies, 331 subjects with active Crohn's disease were treated with either alicaforsen (221 subjects) or placebo (110 subjects) administered via 2-hour intravenous infusion 3 times a week for 4 weeks. Patients then returned for follow-up every 2 weeks. The primary end point was clinical remission by week 12. Secondary end points included clinical response and remission in relation to previous use of other biologics including tumor necrosis factor-α antagonists and presence of fistulous disease. Results: The results, whether combined or analyzed individually, failed to demonstrate statistical significance as a measure of its primary outcome (alicaforsen 33.9% vs placebo 34.5%; P = .89). In addition, no statistical differences in response were observed between alicaforsen and placebo in subjects who were previously treated with anti-tumor necrosis factor-α therapy or had baseline fistulizing disease. There were no significant differences in adverse events from placebo apart from a higher infusion reaction rate. Conclusions: In the subject population studied, alicaforsen failed to demonstrate efficacy in any of its primary outcome measures. Alicaforsen was well-tolerated.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Clinical Gastroenterology and Hepatology - Volume 5, Issue 2, February 2007, Pages 215-220
Journal: Clinical Gastroenterology and Hepatology - Volume 5, Issue 2, February 2007, Pages 215-220
نویسندگان
Bruce Yacyshyn, William Y. Chey, Mark K. Wedel, Rosie Z. Yu, David Paul, Emil Chuang,