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)
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
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
