Status:
COMPLETED
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Daiichi Sankyo Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.
Eligibility Criteria
Inclusion
- 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:
- Methotrexate (MTX) 7.5 - 25 mg/week
- Hydroxychloroquine (HCQ) \</= 400 mg/day
- Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
- Leflunomide 5 - 20 mg/day
- Azathioprine 150 mg/day or 2 mg/kg/day
- Combinations of MTX, HCQ, and/or SSZ allowed
Exclusion
- Prior to Day 0, use of
- Abatacept
- Rituximab within 6 months
- Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
- Etanercept or Anakinra within 28 days
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01878123
Start Date
April 1 2013
End Date
July 1 2014
Last Update
September 30 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
3
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231