Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedImmune LLC
With
Daiichi Sankyo Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must be able to provide written informed consent
Body mass index 18.5 to 35.0 kg/m2
Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
Global Functional Class I, II, or III according to ACR 1991 revised criteria
Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)
Use of \>/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for \>/= 2 weeks prior to randomization
Use of \>/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for \>/= 3 months and a stable dose for \>/= 6 weeks prior to randomization
Stable use of low dose oral corticosteroids (\</= 10 mg prednisone per day or equivalent) is allowed; subjects must be on a stable dose for \>/= 4 weeks prior to randomization
You may not be if
Prior to Day 0, use of:
1. Rituximab within 6 months
2. Abatacept within 3 months
3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
4. Etanercept, Anakinra, immunoglobulin or blood products within 28 days
5. Prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, Janus kinase (JAK) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer
6. Prior exposure to T cell depleting agents such as Campath (alemtuzumab)
Evidence of any active or recent infection
History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed
History of allergic reactions
History of anaphylaxis or allergic diathesis
Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
Evidence of active or latent tuberculosis
Vaccination with live attenuated viruses within the 2 weeks prior to Day 0
