Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:4/2/2016
Start Date:June 2014
End Date:March 2015

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

This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation,
multi-center 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

- 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 ( equivalent) is allowed; subjects must be on a stable dose for >/= 4 weeks prior to
randomization

Exclusion Criteria:

- Prior to Day 0, use of:

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
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Frederick, Maryland 21702
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