Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women ≥ 18 and ≤ 80 years old
Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline
Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening:
* erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr
* serum C-reactive protein (CRP) \> 1.0 mg/dL
Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study
Subject has no known history of active tuberculosis
You may not be if
Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
Use of commercially available or investigational biologic therapies for RA as follows:
* anakinra, etanercept within 1 month prior to first dose of IP
* infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of IP
* other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of IP
Previous receipt of rituximab or a biosimilar of rituximab
