Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: AMP-110Other: Placebo
- Registration Number
- NCT01878123
- Lead Sponsor
- MedImmune LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
-
Must be able to provide written informed consent
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Body mass index 18.5 to 35.0 kg/m2
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Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
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Global Functional Class I, II, or III according to ACR 1991 revised criteria
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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
-
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
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History of systemic autoimmune disease other than Rheumatoid Arthritis
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History of allergic reactions to other protein therapeutics such as monoclonal antibodies or fusion proteins
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History of anaphylaxis or allergic diathesis
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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
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Evidence of active or latent tuberculosis
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Vaccination wtih live attenuated viruses within the 2 weeks prior to Day 0
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMP-110 AMP-110 Escalating doses of AMP-110 Placebo Placebo -
- Primary Outcome Measures
Name Time Method Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo From start of study drug administration through Day 56 Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)
Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials From start of study drug administration through Day 56 Based on the occurrence of dose-limiting toxicities (through Day 14)
- Secondary Outcome Measures
Name Time Method Evaluate pharmacokinetic profile of a single dose of AMP-110 From Day 0 pre-dose through Day 28 Pharmacokinetics evaluated by area under the serum concentration versus time curve (AUC), peak serum concentration (Cmax), and clearance (Cl) of AMP-110
Trial Locations
- Locations (3)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States