Status:
COMPLETED
Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity 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 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center 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
- 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
Exclusion
- Prior to Day 0, use of:
- Rituximab within 6 months
- Abatacept within 3 months
- Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
- Etanercept, Anakinra, immunoglobulin or blood products within 28 days
- 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
- 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
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02277574
Start Date
June 1 2014
End Date
July 1 2015
Last Update
November 21 2016
Active Locations (7)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Omega Research Consultants, LLC.
Orlando, Florida, United States, 32804
3
Arthritis Center, Inc.
Palm Harbor, Florida, United States, 34684
4
Arthritis Treatment Center
Frederick, Maryland, United States, 21702