Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2014
End Date:December 2014

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Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)

The purpose of this study is to examine the relationship between anti-drug antibodies, serum
drug concentrations, and clinical response for rheumatoid arthritis patients being treated
with etanercept, adalimumab or infliximab.

cross-sectional Population will be selected through convenience sampling. Patients
sequentially visiting the rheumatology clinic for routine care who are receiving etanercept,
adalimumab, or infliximab for between 6 and 24 months will be evaluated for eligibility and
interest in participation. A maximum of 200 patients per treatment will be enrolled.

Inclusion Criteria:

1. Age 18 years or older.

2. Diagnosis of RA based on the 1987 American College of Rheumatology revised criteria

3. Current continuous treatment with either etanercept, adalimumab, or infliximab for a
minimum of 6 months and maximum of 24 months.

Exclusion Criteria:

1. Treatment with biosimilar or investigational etanercept, adalimumab, or infliximab
within past 6 months.

2. Treatment with any other investigational drugs within past 3 months or five half
lives of the drug, whichever is longer.

3. Any medical condition that would interfere with rheumatoid arthritis evaluation or
other study assessments (eg, fibromyalgia, lupus).
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Austin, Texas 78731
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Baltimore, Maryland 21286
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Brooklyn, New York 11235
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Charlotte, North Carolina 28210
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Chesapeake, Virginia 23320
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Ciudad Autónoma de Buenos Aires / Buenos Aires, Buenos Aires / Argentina
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Debary, FL
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Fall River, Massachusetts 02720
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Florissant, Missouri 63031
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Fort Lauderdale, Florida 33334
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Gainesville, Florida 32607
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Gainesville, Georgia 30501
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Glendale, Arizona 85304
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Hendersonville, Tennessee 37075
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Hixon, Tennessee 37343
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Hot Springs, Arkansas 71913
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Lincoln, Nebraska 68516
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Midland Park, New Jersey 07432
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North Charleston, South Carolina 29406
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Phoenix, Arizona 85032
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Plainview, New York 11803
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Sacramento, California 95816
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San Jose, California 95035
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Spokane, Washington 99204
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Tampa, Florida 33607
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Tomball, Texas 77375
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Wichita, Kansas 67214
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Wyomissing, Pennsylvania 19610
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