Can rheumatoid arthritis (RA) registries provide contextual safety data for modern RA clinical trials? The case for mortality and cardiovascular disease.
Kaleb D MichaudNiklas BerglindStefan FranzénThomas FrisellChristopher GarwoodJeffrey D GreenbergMeilien HoMarie HolmqvistLaura HorneEisuke InoueFredrik NybergDimitrios A PappasGeorge ReedDeborah P M SymmonsEiichi TanakaTrung N TranSuzanne M M VerstappenEveline Wesby-van SwaayHisashi YamanakaJohan AsklingPublished in: Annals of the rheumatic diseases (2016)
This coordinated approach to contextualising RA RCT safety data demonstrated reasonable differences and consistency in rates for mortality and CVD across registries, and comparable RCT rates, and may serve as a model method to supplement clinical trial analyses for drug development programmes.
Keyphrases
- rheumatoid arthritis
- clinical trial
- disease activity
- cardiovascular disease
- cardiovascular events
- electronic health record
- ankylosing spondylitis
- interstitial lung disease
- big data
- phase ii
- risk factors
- open label
- systemic lupus erythematosus
- double blind
- type diabetes
- study protocol
- coronary artery disease
- randomized controlled trial
- metabolic syndrome
- systemic sclerosis
- data analysis
- cardiovascular risk factors