The PRO-ACT database: design, initial analyses, and predictive features
To pool data from completed amyotrophic lateral sclerosis (ALS) clinical trials and create an open-access resource that enables greater understanding of the phenotype and biology of ALS. Clinical trials data were pooled from 16 completed phase II/III ALS clinical trials and one observational study....
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| Veröffentlicht in: | Neurology Jg. 83; H. 19; S. 1719 |
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| Hauptverfasser: | , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
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United States
04.11.2014
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| ISSN: | 1526-632X, 1526-632X |
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| Abstract | To pool data from completed amyotrophic lateral sclerosis (ALS) clinical trials and create an open-access resource that enables greater understanding of the phenotype and biology of ALS.
Clinical trials data were pooled from 16 completed phase II/III ALS clinical trials and one observational study. Over 8 million de-identified longitudinally collected data points from over 8,600 individuals with ALS were standardized across trials and merged to create the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. This database includes demographics, family histories, and longitudinal clinical and laboratory data. Mixed effects models were used to describe the rate of disease progression measured by the Revised ALS Functional Rating Scale (ALSFRS-R) and vital capacity (VC). Cox regression models were used to describe survival data. Implementing Bonferroni correction, the critical p value for 15 different tests was p = 0.003.
The ALSFRS-R rate of decline was 1.02 (±2.3) points per month and the VC rate of decline was 2.24% of predicted (±6.9) per month. Higher levels of uric acid at trial entry were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.02). Higher levels of creatinine at baseline were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.01). Finally, higher body mass index (BMI) at baseline was associated with longer survival (p < 0.0001).
The PRO-ACT database is the largest publicly available repository of merged ALS clinical trials data. We report that baseline levels of creatinine and uric acid, as well as baseline BMI, are strong predictors of disease progression and survival. |
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| AbstractList | To pool data from completed amyotrophic lateral sclerosis (ALS) clinical trials and create an open-access resource that enables greater understanding of the phenotype and biology of ALS.
Clinical trials data were pooled from 16 completed phase II/III ALS clinical trials and one observational study. Over 8 million de-identified longitudinally collected data points from over 8,600 individuals with ALS were standardized across trials and merged to create the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. This database includes demographics, family histories, and longitudinal clinical and laboratory data. Mixed effects models were used to describe the rate of disease progression measured by the Revised ALS Functional Rating Scale (ALSFRS-R) and vital capacity (VC). Cox regression models were used to describe survival data. Implementing Bonferroni correction, the critical p value for 15 different tests was p = 0.003.
The ALSFRS-R rate of decline was 1.02 (±2.3) points per month and the VC rate of decline was 2.24% of predicted (±6.9) per month. Higher levels of uric acid at trial entry were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.02). Higher levels of creatinine at baseline were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.01). Finally, higher body mass index (BMI) at baseline was associated with longer survival (p < 0.0001).
The PRO-ACT database is the largest publicly available repository of merged ALS clinical trials data. We report that baseline levels of creatinine and uric acid, as well as baseline BMI, are strong predictors of disease progression and survival. To pool data from completed amyotrophic lateral sclerosis (ALS) clinical trials and create an open-access resource that enables greater understanding of the phenotype and biology of ALS.OBJECTIVETo pool data from completed amyotrophic lateral sclerosis (ALS) clinical trials and create an open-access resource that enables greater understanding of the phenotype and biology of ALS.Clinical trials data were pooled from 16 completed phase II/III ALS clinical trials and one observational study. Over 8 million de-identified longitudinally collected data points from over 8,600 individuals with ALS were standardized across trials and merged to create the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. This database includes demographics, family histories, and longitudinal clinical and laboratory data. Mixed effects models were used to describe the rate of disease progression measured by the Revised ALS Functional Rating Scale (ALSFRS-R) and vital capacity (VC). Cox regression models were used to describe survival data. Implementing Bonferroni correction, the critical p value for 15 different tests was p = 0.003.METHODSClinical trials data were pooled from 16 completed phase II/III ALS clinical trials and one observational study. Over 8 million de-identified longitudinally collected data points from over 8,600 individuals with ALS were standardized across trials and merged to create the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. This database includes demographics, family histories, and longitudinal clinical and laboratory data. Mixed effects models were used to describe the rate of disease progression measured by the Revised ALS Functional Rating Scale (ALSFRS-R) and vital capacity (VC). Cox regression models were used to describe survival data. Implementing Bonferroni correction, the critical p value for 15 different tests was p = 0.003.The ALSFRS-R rate of decline was 1.02 (±2.3) points per month and the VC rate of decline was 2.24% of predicted (±6.9) per month. Higher levels of uric acid at trial entry were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.02). Higher levels of creatinine at baseline were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.01). Finally, higher body mass index (BMI) at baseline was associated with longer survival (p < 0.0001).RESULTSThe ALSFRS-R rate of decline was 1.02 (±2.3) points per month and the VC rate of decline was 2.24% of predicted (±6.9) per month. Higher levels of uric acid at trial entry were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.02). Higher levels of creatinine at baseline were predictive of a slower drop in ALSFRS-R (p = 0.01) and VC (p < 0.0001), and longer survival (p = 0.01). Finally, higher body mass index (BMI) at baseline was associated with longer survival (p < 0.0001).The PRO-ACT database is the largest publicly available repository of merged ALS clinical trials data. We report that baseline levels of creatinine and uric acid, as well as baseline BMI, are strong predictors of disease progression and survival.CONCLUSIONThe PRO-ACT database is the largest publicly available repository of merged ALS clinical trials data. We report that baseline levels of creatinine and uric acid, as well as baseline BMI, are strong predictors of disease progression and survival. |
| Author | Sherman, Alexander Cudkowicz, Merit Sinani, Ervin Katsovskiy, Igor Atassi, Nazem Walker, Jason Leitner, Melanie Berry, James Shui, Amy Zach, Neta Schoenfeld, David |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25298304$$D View this record in MEDLINE/PubMed |
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| References_xml | – reference: 22922503 - Neurodegener Dis. 2013;12(2):81-90 – reference: 15534251 - Neurology. 2004 Nov 9;63(9):1656-61 – reference: 17709710 - Neurology. 2007 Aug 21;69(8):776-84 – reference: 19961264 - Amyotroph Lateral Scler. 2010 May 3;11(3):266-71 – reference: 21956723 - Neurology. 2011 Oct 11;77(15):1432-7 – reference: 22728481 - Intern Med. 2012;51(12):1501-8 – reference: 18574760 - Amyotroph Lateral Scler. 2008 Jun;9(3):163-7 – reference: 8628460 - Neurology. 1996 May;46(5):1244-9 – reference: 8960715 - Neurology. 1996 Dec;47(6):1383-8 – reference: 22580741 - Curr Neurol Neurosci Rep. 2012 Aug;12(4):367-75 – reference: 11465936 - Amyotroph Lateral Scler Other Motor Neuron Disord. 2001 Mar;2(1):9-18 – reference: 20063429 - Mov Disord. 2010 Jan 30;25(2):224-8 – reference: 20363190 - Lancet Neurol. 2010 May;9(5):481-8 – reference: 11386269 - N Engl J Med. 2001 May 31;344(22):1688-700 – reference: 12939417 - Neurology. 2003 Aug 26;61(4):456-64 – reference: 8302340 - N Engl J Med. 1994 Mar 3;330(9):585-91 – reference: 19969067 - Free Radic Biol Med. 2010 Mar 1;48(5):629-41 – reference: 23042862 - Science. 2012 Oct 5;338(6103):29 – reference: 19073945 - Neurology. 2009 Feb 24;72(8):705-11 – reference: 19961263 - Amyotroph Lateral Scler. 2010 May 3;11(3):259-65 – reference: 16802291 - Ann Neurol. 2006 Jul;60(1):22-31 – reference: 11033417 - Free Radic Biol Med. 2000 Oct 1;29(7):652-8 – reference: 12021952 - J Neurol. 2002 May;249(5):609-15 – reference: 8757041 - Neurology. 1996 Aug;47(2):571-3 – reference: 22323210 - J Neurol. 2012 Sep;259(9):1923-8 – reference: 24070404 - Amyotroph Lateral Scler Frontotemporal Degener. 2014 Mar;15(1-2):119-29 – reference: 10467383 - Mult Scler. 1999 Aug;5(4):244-50 – reference: 10227630 - Neurology. 1999 Apr 22;52(7):1427-33 – reference: 19822770 - Arch Neurol. 2009 Dec;66(12):1460-8 – reference: 15204012 - Amyotroph Lateral Scler Other Motor Neuron Disord. 2004 Jun;5(2):107-17 – reference: 18413464 - Arch Neurol. 2008 Jun;65(6):716-23 – reference: 10636125 - Neurology. 2000 Jan 11;54(1):53-7 – reference: 21607987 - Muscle Nerve. 2011 Jul;44(1):20-4 – reference: 23678880 - Amyotroph Lateral Scler Frontotemporal Degener. 2013 May;14 Suppl 1:53-61 – reference: 16036424 - Amyotroph Lateral Scler Other Motor Neuron Disord. 2005 Mar;6(1):37-44 – reference: 18551622 - Muscle Nerve. 2008 Jul;38(1):837-44 – reference: 19552925 - J Neurol Sci. 2009 Oct 15;285(1-2):95-9 – reference: 22117131 - Amyotroph Lateral Scler. 2012 Jan;13(1):110-8 |
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| Snippet | To pool data from completed amyotrophic lateral sclerosis (ALS) clinical trials and create an open-access resource that enables greater understanding of the... |
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| SubjectTerms | Amyotrophic Lateral Sclerosis - diagnosis Amyotrophic Lateral Sclerosis - physiopathology Amyotrophic Lateral Sclerosis - therapy Clinical Trials as Topic - statistics & numerical data Database Management Systems Datasets as Topic - statistics & numerical data Disease Progression Humans Longitudinal Studies Observational Studies as Topic - statistics & numerical data Predictive Value of Tests Research Design |
| Title | The PRO-ACT database: design, initial analyses, and predictive features |
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