Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity 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 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.

Key facts

Study ID

NCT02277574

Run by

MedImmune LLC

People needed

29

Starts

2014-06-01

Expected to finish

2015-07-01

Last updated by the study team

2016-11-21

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
• 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 (</= 10 mg prednisone per day or equivalent) is allowed; subjects must be on a stable dose for >/= 4 weeks prior to randomization

You may not qualify if…

• Prior to Day 0, use of:
• Rituximab within 6 months
• Abatacept within 3 months
• Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
• Etanercept, Anakinra, immunoglobulin or blood products within 28 days
• 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
• 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

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Omega Research Consultants, LLC. — Orlando, Florida, United States
• Arthritis Center, Inc. — Palm Harbor, Florida, United States
• Arthritis Treatment Center — Frederick, Maryland, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, 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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