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- Chapter 3: Product Safety Monitoring in Clinical Trials in Pharmacovigilance: A Practical Approach. 1st ed..in: Doan T. Renz C. Lievano F. Bhattacharya M. Scarazzini L. Elsevier, 2018 (eBook ISBN: 9780323581172(Paperback ISBN:9780323581165))
- Prevention trials: their place in how we understand the value of prevention strategies.Annu Rev Public Health. 2010; 31: 105-120
- Editorial: prevention of rheumatoid arthritis: now is the time, but how to proceed?.Arthritis Rheumatol. 2017; 69: 873-877
- Management of Safety Information from Clinical Trials. vol. 2005. 2005 (Geneva)
- Cardiac Safety Research Consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward.Am Heart J. 2014 Sep; 168 (Epub 2014 Jun 6. PubMed PMID: 25173536): 262-272https://doi.org/10.1016/j.ahj.2014.06.003
- U.S. FDA Guidance for Industry. Drug-Induced Liver Injury: Premarketing Clinical Evaluation.Drug Safety, July 2009 (2009)
- Immunogenicity and other problems associated with the use of biopharmaceuticals.Ther Adv Drug Saf. 2011; 2: 113-128
- Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study.Arthritis Rheum. 2002 Sep; 46 (PubMed PMID: 12355475): 2287-2293
- Clinical connection between rheumatoid arthritis and liver damage.Rheumatol Int. 2018 May; 38 (Epub 2018 Apr 7. Review. PubMed PMID: 29627896): 715-724https://doi.org/10.1007/s00296-018-4021-5
- Incidence of malignancy in adult patients with rheumatoid arthritis: a meta-analysis.Arthritis Res Ther. 2015 Aug 15; 17 (Erratum in: Arthritis Res Ther. 2016;18(1):100. PubMed PMID: 26271620; PubMed Central PMCID: PMC4536786): 212https://doi.org/10.1186/s13075-015-0728-9. Review
- Prevalence of and factors associated with renal dysfunction in rheumatoid arthritis patients: a cross-sectional study in community hospitals.Clin Rheumatol. 2017 Dec; 36 (Epub 2017 Sep 7. PubMed PMID: 28884373; PubMed Central PMCID: PMC5681610): 2673-2682https://doi.org/10.1007/s10067-017-3804-5
- Increased cardiovascular risk in rheumatoid arthritis: mechanisms and implications.BMJ. 2018 Apr 23; 361 (Review. PubMed PMID: 29685876): k1036https://doi.org/10.1136/bmj.k1036
- Incident myocardial infarction associated with major types of arthritis in the general population: a systematic review and meta-analysis.Ann Rheum Dis. 2017 Aug; 76 (Epub 2017 Feb 20. Review. PubMed PMID: 28219882): 1396-1404https://doi.org/10.1136/annrheumdis-2016-210275
- Changes in lipid levels with inflammation and therapy in RA: a maturing paradigm.Nat Rev Rheumatol. 2013 Sep; 9 (Epub 2013 Jun 18. Review. PubMed PMID: 23774906): 513-523https://doi.org/10.1038/nrrheum.2013.91
- Increased unrecognized coronary heart disease and sudden deaths in rheumatoid arthritis: a population-based cohort study.Arthritis Rheum. 2005 Feb; 52 (Review. PubMed PMID: 15693010): 402-411
- Anticyclic citrullinated protein antibodies are implicated in the development of cardiovascular disease in rheumatoid arthritis.Arterioscler Thromb Vasc Biol. 2014 Dec; 34 (Epub 2014 Sep 25. PubMed PMID: 25256232): 2706-2716https://doi.org/10.1161/ATVBAHA.114.304475
- Association between anti-cyclic citrullinated peptide antibodies and ischemic heart disease in patients with rheumatoid arthritis.Arthritis Rheum. 2009 Apr 15; 61 (PubMed PMID: 19333979): 419-424https://doi.org/10.1002/art.24390
- Committee for Medicinal Products for Human Use, 2005.June 2005
- Differential dropout and bias in randomised controlled trials: when it matters and when it may not.BMJ. 2013 Jan 21; 346 (PubMed PMID: 23338004; PubMed Central PMCID: PMC4688419): e8668https://doi.org/10.1136/bmj.e8668
- Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH Harmonized Tripartite Guideline.1994
- Doan T. Renz C. Lievano F. Bhattacharya M. Scarazzini L. Chapter 4: Causality Assessment and Examples of Adverse Drug Reactions (Drug-Induced Liver Injury, Renal, Skin, and Major Adverse Cardiac Events). 1st ed. Elsevier, 2018 (eBook ISBN: 9780323581172(Paperback ISBN: 9780323581165))
- Guidelines for Preparing Core Clinical-Safety Information on Drugs.(Geneva)2nd ed. 1999
- The environment and disease: association or causation?.Proc R Soc Med. 1965; 58: 295-300
- A method for estimating the probability of adverse drug reactions.Clin Pharmacol Ther. 1981 Aug; 30 (PubMed PMID: 7249508): 239-245
- The Use of the WHO-UMC System for Standardised Casse Causality Assessment.2018
- U.S. FDA Guidance for Industry and Investigators. Safety Reporting Requirements for INDs and BA/BE Studies.December 2012
- U.S. FDA Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Draft Guidance.July 2014
- Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods.Am J Cardiol. 2007 Jun 18; 99 (Epub 2007 Apr 16. PubMed PMID: 17599422): 21i-33i
- Effects of intensive glucose lowering in type 2 diabetes.N Engl J Med. 2008 Jun 12; 358 (PubMed PMID: 18539917; PubMed Central PMCID: PMC4551392): 2545-2559https://doi.org/10.1056/NEJMoa0802743. Epub 2008 Jun 6
- Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.Am J Cardiol. 2007 Jun 18; 99 (Epub 2007 Apr 17. PubMed PMID: 17599428): 80i-89i
- JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein.N Engl J Med. 2008 Nov 20; 359 (Epub 2008 Nov 9. PubMed PMID:18997196): 2195-2207https://doi.org/10.1056/NEJMoa0807646
- The JUPITER trial: results, controversies, and implications for prevention.Circ Cardiovasc Qual Outcomes. 2009; 2: 279-285
- Number needed to treat with rosuvastatin to prevent first cardiovascular events and death among men and women with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin (JUPITER).Circ Cardiovasc Qual Outcomes. 2009 Nov; 2 (Epub 2009 Sep 22. PubMed PMID: 20031900): 616-623https://doi.org/10.1161/CIRCOUTCOMES.109.848473
- Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial.Arthritis Rheum. 2007 May; 56 (PubMed PMID: 17469099): 1424-1432
- Brief Report: Clinical Trials Aiming to Prevent Rheumatoid Arthritis Cannot Detect Prevention Without Adequate Risk Stratification: A Trial of Methotrexate Versus Placebo in Undifferentiated Arthritis as an Example.Arthritis Rheumatol. 2017 May; 69 (Epub 2017 Mar 31. PubMed PMID:28217975): 926-931https://doi.org/10.1002/art.40062
van Schaardenburg, D.I., Statins to prevent rheumatoid arthritis (STAPRA) prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multicenter double-blind randomized placebo-controlled trial. Trial NL5036 (NTR5265).
- Effects of B-cell directed therapy on the preclinical stage of rheumatoid arthritis: the PRAIRI study.Ann Rheum Dis. 2019 Feb; 78 (Epub 2018 Dec 1. PubMed PMID: 30504445; PubMed Central PMCID: PMC6352407): 179-185https://doi.org/10.1136/annrheumdis-2017-212763
- Arthritis Prevention in the Pre-clinical Phase of RA with Abatacept (APIPPRA).2014 (ISRCTN No. 46017566)
Deane, K.D., Holers, M, Striebich, C. Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA). ClinicalTrials.gov identifier NCT02603146.
- Treat Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid Arthritis.Treat Earlier, 2015 (Trial NL4599 (NTR4853))