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 |
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.
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.
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).
We found this trial at
35
sites
Ciudad Autónoma de Buenos Aires / Buenos Aires, Buenos Aires / Argentina
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