Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies.
Mark C GenoveseHerbert KellnerYasumasa AraiRafael MunizRieke E AltenPublished in: RMD open (2021)
Efficacy, safety and immunogenicity were similar among patients with RA treated with FKB327 or the RP for up to 2 years, and were not affected by single- or double-switching treatment.
Keyphrases
- rheumatoid arthritis
- open label
- clinical trial
- double blind
- placebo controlled
- phase ii
- phase iii
- study protocol
- disease activity
- ankylosing spondylitis
- electronic health record
- interstitial lung disease
- randomized controlled trial
- juvenile idiopathic arthritis
- machine learning
- squamous cell carcinoma
- systemic lupus erythematosus
- big data
- systemic sclerosis
- radiation therapy
- combination therapy