Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
NCT ID: NCT01878123
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2013-04-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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AMP-110
Escalating doses of AMP-110
AMP-110
Dose levels 1 through 7: Single intravenous infusion on Day 0
Placebo
Placebo
Dose levels 4 through 7: Single intravenous infusion on Day 0
Interventions
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AMP-110
Dose levels 1 through 7: Single intravenous infusion on Day 0
Placebo
Dose levels 4 through 7: Single intravenous infusion on Day 0
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AMP-110-01
Identifier Type: -
Identifier Source: org_study_id
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