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
Stable use of \>/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for \>/= 4 weeks prior to Day 0, including:
1. Methotrexate (MTX) 7.5 - 25 mg/week
2. Hydroxychloroquine (HCQ) \</= 400 mg/day
3. Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
4. Leflunomide 5 - 20 mg/day
5. Azathioprine 150 mg/day or 2 mg/kg/day
6. Combinations of MTX, HCQ, and/or SSZ allowed
You may not be if
Prior to Day 0, use of
1. Abatacept
2. Rituximab within 6 months
3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
4. Etanercept or Anakinra within 28 days
5. Immunoglobulin or blood products within 28 days
Evidence of any active or recent infection including ongoing, chronic infectious disease such as chronic renal infection or chronic chest infection with bronchiectasis or sinusitis
History of systemic autoimmune disease other than Rheumatoid Arthritis
History of allergic reactions to other protein therapeutics such as monoclonal antibodies or fusion proteins
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 wtih live attenuated viruses within the 2 weeks prior to Day 0
Evidence of infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1 or 2, or active infection with hepatitis A
Pregnant or breastfeeding women
Clareo Health | Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
