A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:11/30/2017
Start Date:December 2014
End Date:July 2016

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A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate

The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison
to Humira® in rheumatoid arthritis patients who have inadequate disease control on
methotrexate.


Inclusion Criteria:

1. Male or female aged 18 years or over

2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months

3. Patient has active RA

4. Patient has taken a stable dose of methotrexate for at least 3 months

Exclusion Criteria:

1. Patient has been previously treated with adalimumab

2. Patient has been previously treated or has ongoing treatment with prohibited
medications

3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks

4. Patient has positive result for HIV, HBV, HCV or TB infection

Other Inclusion/Exclusion criteria may apply.
We found this trial at
17
sites
2144
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Brandon, FL
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Amarillo, TX
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Austin, TX
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Boca Raton, FL
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Duncansville, Pennsylvania 16635
2200
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Duncansville, PA
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Durham, NC
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Jacksonville, FL
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Lansing, MI
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1235
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Mesquite, TX
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Miami, FL
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Miami Lakes, FL
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2025
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Middleburg Heights, OH
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97
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Palm Desert, CA
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333
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Peoria, AZ
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6666
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Plovdiv,
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2148
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Sarasota, FL
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1401
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Shreveport, LA
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