NCT01313208
Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
Sponsored by Amgen
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
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Birmingham, Alabama, United States
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Tuscaloosa, Alabama, United States
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Peoria, Arizona, United States
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Scottsdale, Arizona, United States
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Encino, California, United States
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Hemet, California, United States
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Inglewood, California, United States
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La Jolla, California, United States
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Murrieta, California, United States
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Santa Maria, California, United States
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Tustin, California, United States
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Upland, California, United States
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Victorville, California, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Ocala, Florida, United States
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Sarasota, Florida, United States
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Sebring, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Meridian, Idaho, United States
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Springfield, Illinois, United States
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Lexington, Kentucky, United States
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Frederick, Maryland, United States
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Lansing, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Bismarck, North Dakota, United States
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Akron, Ohio, United States
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Mayfield Village, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Erie, Pennsylvania, United States
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Greer, South Carolina, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Chesapeake, Virginia, United States
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Seattle, Washington, United States
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Burlington, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Eustache, Quebec, Canada
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
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