Can rheumatoid arthritis (RA) registries provide contextual safety data for modern RA clinical trials? The case for mortality and cardiovascular disease

Kaleb Michaud; Niklas Berglind; Stefan Franzén; Thomas Frisell; Christopher Garwood; Jeffrey D Greenberg; Meilien Ho; Marie Holmqvist; Laura Horne; Eisuke Inoue; Fredrik Nyberg; Dimitrios A Pappas; George Reed; Deborah Symmons; Eiichi Tanaka; Trung N Tran; Suzanne M M Verstappen; Eveline Wesby-van Swaay; Hisashi Yamanaka; Johan Askling

doi:10.1136/annrheumdis-2015-208698

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Clinical and epidemiological research

Extended report

Can rheumatoid arthritis (RA) registries provide contextual safety data for modern RA clinical trials? The case for mortality and cardiovascular disease

Authors

Kaleb Michaud University of Nebraska Medical Center, Omaha, Nebraska, USA National Data Bank for Rheumatic Diseases, Wichita, Kansas, USA PubMed articles Google scholar articles
Niklas Berglind Biometric & Information Sciences, Global Medicines Development, AstraZeneca R&D, Mölndal, Sweden PubMed articles Google scholar articles
Stefan Franzén Biometric & Information Sciences, Global Medicines Development, AstraZeneca R&D, Mölndal, Sweden PubMed articles Google scholar articles
Thomas Frisell Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden PubMed articles Google scholar articles
Christopher Garwood Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, UK PubMed articles Google scholar articles
Jeffrey D Greenberg NYU School of Medicine, New York, New York, USA Corrona LLC, Southborough, Massachusetts, USA PubMed articles Google scholar articles
Meilien Ho Clinical, Global Medicines Development, AstraZeneca R&D, Macclesfield, UK PubMed articles Google scholar articles
Marie Holmqvist Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden PubMed articles Google scholar articles
Laura Horne Medical Evidence & Observational Research Centre, Global Medicines Development, AstraZeneca, Wilmington, Delaware, USA PubMed articles Google scholar articles
Eisuke Inoue Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan PubMed articles Google scholar articles
Fredrik Nyberg Medical Evidence & Observational Research Centre, Global Medicines Development, AstraZeneca R&D, Mölndal, Sweden Occupational and Environmental Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden PubMed articles Google scholar articles
Dimitrios A Pappas Corrona LLC, Southborough, Massachusetts, USA The College of Physicians and Surgeons, Columbia University Medical Center, New York, New York, USA PubMed articles Google scholar articles
George Reed Corrona LLC, Southborough, Massachusetts, USA University of Massachusetts Medical School, Worcester, Massachusetts, USA PubMed articles Google scholar articles
Deborah Symmons Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, UK NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK PubMed articles Google scholar articles
Eiichi Tanaka Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan PubMed articles Google scholar articles
Trung N Tran MedImmune, Gaithersburg, Maryland, USA PubMed articles Google scholar articles
Suzanne M M Verstappen Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, UK PubMed articles Google scholar articles
Eveline Wesby-van Swaay Patient Safety, GRAPSQA, Global Medicines Development, AstraZeneca R&D, Mölndal, Sweden PubMed articles Google scholar articles
Hisashi Yamanaka Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan PubMed articles Google scholar articles
Johan Askling Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden Department of Rheumatology, Karolinska University Hospital, Stockholm, Sweden PubMed articles Google scholar articles

Correspondence to Dr Kaleb Michaud, Department of Medicine, University of Nebraska Medical Center, 986270 Nebraska Medical Center, Omaha NE 68198-6270, USA; kmichaud{at}unmc.edu

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Citation

Michaud K, Berglind N, Franzén S, et al

Can rheumatoid arthritis (RA) registries provide contextual safety data for modern RA clinical trials? The case for mortality and cardiovascular disease

Annals of the Rheumatic Diseases 2016;75:1797-1805.

Publication history

Received October 1, 2015
Revised December 30, 2015
Accepted January 16, 2016
First published February 8, 2016.

Online issue publication

October 25, 2017

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