Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:11/30/2013
Start Date:April 2013

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A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis


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.


Inclusion Criteria:

- 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:

1. Methotrexate (MTX) 7.5 - 25 mg/week

2. Hydroxychloroquine (HCQ)
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:

- Prior to Day 0, use of

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
We found this trial at
4
sites
Sarasota, Florida 34239
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Sarasota, FL
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175 Meadowbrook Lane
, Pennsylvania 16635
814-693-0300
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, PA
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8144 Walnut Hill Lane
Northeast, Texas 75231
214-879-6737
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Northeast, TX
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Anniston, Alabama 36207
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Anniston, AL
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