Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
NCT ID: NCT02277574
Last Updated: 2016-11-21
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
29 participants
INTERVENTIONAL
2014-06-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Crossover Group 1
Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo
AMP-110
2, 5, or 10 mg/kg
Crossover Group 2
Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week
Placebo
Placebo
Interventions
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AMP-110
2, 5, or 10 mg/kg
Placebo
Placebo
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
* 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 Criteria
1. Rituximab within 6 months
2. Abatacept within 3 months
3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
4. Etanercept, Anakinra, immunoglobulin or blood products within 28 days
5. 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
6. 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
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
Omega Research Consultants, LLC.
Orlando, Florida, United States
Arthritis Center, Inc.
Palm Harbor, Florida, United States
Arthritis Treatment Center
Frederick, Maryland, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 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-110-02
Identifier Type: -
Identifier Source: org_study_id