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 |
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) = 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:
- 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
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