The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects
achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept
50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.
Inclusion Criteria:
- Adults with RA (ACR criteria) for greater than or equal to 6 months
- Infliximab treatment for at least 18 weeks
- Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every
4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)
- Failing infliximab defined by ALL of the following at screening and baseline visit:
Disease Activity Score (DAS 28) greater than or equal to 4. 5, greater than or equal to
5 swollen joints, greater than or equal to 5 tender joints
- Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or
equal to 10 mg/week at least 10 weeks prior to screening
- Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including
sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to
screening
- Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks
prior to screening
- Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to
1 week prior to screening
Exclusion Criteria:
- ACR functional class IV - Prior treatment with etanercept
- Receipt of any investigational drug/biologic within 28 days of study drug initiation
- Active infection or predisposition to infection
- Elective surgery planned during study period
- Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4
weeks prior to screening
- Contraindications to etanercept as defined in the package insert
- Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV
congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating
events suggestive of multiple sclerosis (MS); Known HIV-positive status;
Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus
Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure)
or positive PPD without adequate TB prophylaxis
Research Site, Montgomery, Alabama, United States
Research Site, Huntsville, Alabama, United States
Research Site, Scottsdale, Arizona, United States
Research Site, Paradise Valley, Arizona, United States
Research Site, Little Rock, Arkansas, United States
Research Site, Long Beach, California, United States
Research Site, Los Angeles, California, United States
Research Site, Upland, California, United States
Research Site, Hamden, Connecticut, United States
Research Site, Jupiter, Florida, United States
Research Site, Delray Beach, Florida, United States
Research Site, Clearwater, Florida, United States
Research Site, S Miami, Florida, United States
Research Site, Boise, Idaho, United States
Research Site, Coeur d'Alene, Idaho, United States
Research Site, Meridian, Idaho, United States
Research Site, Rockford, Illinois, United States
Research Site, Chicago, Illinois, United States
Research Site, Louisville, Kentucky, United States
Research Site, Columbia, Maryland, United States
Research Site, St. Clair Shores, Michigan, United States
Research Site, Lansing, Michigan, United States
Research Site, Saint Paul, Minnesota, United States
Research Site, Duluth, Minnesota, United States
Research Site, St. Louis, Missouri, United States
Research Site, St Louis, Missouri, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, Manalapan, New Jersey, United States
Research Site, New Brunswick, New Jersey, United States
Research Site, Mercerville, New Jersey, United States
Research Site, Plainview, New York, United States
Research Site, Hewlett, New York, United States
Research Site, New York, New York, United States
Research Site, Syracuse, New York, United States
Research Site, Gastonia, North Carolina, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Toronto, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Duncansville, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Wexford, Pennsylvania, United States
Research Site, Colmar, Pennsylvania, United States
Research Site, Reckledge, Pennsylvania, United States
Research Site, Bethlehem, Pennsylvania, United States
Research Site, Montreal, Quebec, Canada
Research Site, Charleston, South Carolina, United States
Research Site, Memphis, Tennessee, United States
Research Site, Midland, Texas, United States
Research Site, Carrollton, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, San Antonio, Texas, United States
Research Site, Arlington, Virginia, United States
Research Site, Edmonds, Washington, United States
Research Site, Seattle, Washington, United States
Research Site, Racine, Wisconsin, United States
