Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:March 2011
End Date:May 2013

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy

This study is designed to evaluate the effectiveness of adding etanercept to disease
modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid
Arthritis (RA).


Inclusion Criteria:

- Male or female ≥18 and ≤80 years of age at time of screening

- Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of
Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at
least 6 months

- Moderate rheumatoid arthritis during screening, as defined by a disease activity
score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) > 3.2
and ≤ 5.1

- Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined)
and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline.
(A full 66/68 count joint count will be performed at baseline, but only joints in the
28-count joint count will be considered for eligibility. The 28-joint count consists
of the finger joints excluding the distal interphalangeal joints, the wrists, elbows,
shoulders, and knees)

- Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide,
minocycline, and/or hydroxychloroquine

Exclusion Criteria:

- Prosthetic joint infection within 5 years of screening or native joint infection
within 1 year of screening

- Class IV rheumatoid arthritis according to ACR revised response criteria

- Any active infection (including chronic or localized infections) for which
anti-infectives were indicated within 28 days prior to first investigational product
dose

- Previously used more than one experimental biologic DMARD. Patient with prior use of
no more than one experimental biologic is permitted if the subject received no more
than 8 weeks of treatment. The use of the experimental biologic must not have
occurred within 2 months of the first dose of investigational product

- Previously used more than one commercially available biologic DMARD. Subject with
prior use of no more than one commercially available biologic is permitted if the
patient received no more than 8 weeks of treatment and did not discontinue because of
lack of effect. The use of the biologic must not have occurred within 2 months of the
first dose of investigational product. Acceptable prior use of biologics include the
following examples:

- No more than 4 injections of adalimumab

- No more than 8 (50 mg) injections of etanercept

- No more than 2 infusions of infliximab

- No more than 2 infusions of abatacept

- Additional inclusion (exclusion) criteria may apply
We found this trial at
38
sites
1053
mi
from
Jacksonville, FL
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898
mi
from
Akron, OH
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801
mi
from
Atlanta, GA
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683
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from
Birmingham, AL
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645
mi
from
Bismarck, ND
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1185
mi
from
Chesapeake, VA
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349
mi
from
Dallas, TX
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409
mi
from
Denver, CO
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1179
mi
from
Encino, CA
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983
mi
from
Erie, PA
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1105
mi
from
Frederick, MD
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889
mi
from
Greer, SC
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1107
mi
from
Hemet, CA
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1176
mi
from
Inglewood, CA
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1118
mi
from
La Jolla, CA
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779
mi
from
Lansing, MI
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725
mi
from
Lexington, KY
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906
mi
from
Mayfield Village, OH
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1050
mi
from
Meridian, ID
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1124
mi
from
Murrieta, CA
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1080
mi
from
Ocala, FL
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158
mi
from
Oklahoma City, OK
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856
mi
from
Peoria, AZ
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1383
mi
from
Portland, OR
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583
mi
from
San Antonio, TX
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1266
mi
from
Santa Maria, CA
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1143
mi
from
Sarasota, FL
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843
mi
from
Scottsdale, AZ
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1410
mi
from
Seattle, WA
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1184
mi
from
Sebring, FL
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460
mi
from
Springfield, IL
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852
mi
from
St. Clair Shores, MI
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1117
mi
from
Tampa, FL
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656
mi
from
Tuscaloosa, AL
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1152
mi
from
Tustin, CA
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1135
mi
from
Upland, CA
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1108
mi
from
Victorville, CA
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840
mi
from
Winnipeg,
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