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

Completed · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01878123

Run by

MedImmune LLC

People needed

26

Starts

2013-04-01

Expected to finish

2014-07-01

Last updated by the study team

2016-09-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Methotrexate (MTX) 7.5 - 25 mg/week
• Hydroxychloroquine (HCQ) </= 400 mg/day
• Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
• Leflunomide 5 - 20 mg/day
• Azathioprine 150 mg/day or 2 mg/kg/day
• Combinations of MTX, HCQ, and/or SSZ allowed

You may not qualify if…

• Prior to Day 0, use of
• Abatacept
• Rituximab within 6 months
• Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
• Etanercept or Anakinra within 28 days
• 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

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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