Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis.
Andreas KerschbaumerNina Maria StimakovitsJosef S SmolenTijen StefanovaEva ChwalaDaniel AletahaPublished in: Annals of the rheumatic diseases (2023)
Placebo controlled trials lead to smaller effect sizes of active compounds in RCTs compared with the same compound in head-to-head trials. This difference may be explained by potential nocebo effects in placebo-controlled settings and needs to be considered when interpreting head-to-head and placebo-controlled trials, by patients, investigators, sponsors and regulatory agencies.
Keyphrases
- placebo controlled
- double blind
- optic nerve
- rheumatoid arthritis
- phase iii
- end stage renal disease
- study protocol
- phase ii
- ejection fraction
- clinical trial
- prognostic factors
- chronic kidney disease
- squamous cell carcinoma
- peritoneal dialysis
- disease activity
- systemic lupus erythematosus
- systemic sclerosis
- patient reported
- human health