The purpose of this study objective will be to evaluate the efficacy and safety of etanercept 50 mg BIW in RA subjects who showed a sub-optimal response to standard dose etanercept (50 mg QW) and concomitant methotrexate therapy.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Etanercept	Phase IV

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis
• RA with a disease duration greater than or equal to 6 months
• Current and prior but continuous etanercept treatment for at least 5 months
• Subjects must be receiving methotrexate (MTX) at a stable dose greater than or equal to 15 mg/week for at least 4 weeks
• Sub-optimal response to etanercept defined by the presence of the following criteria: 5 or more swollen joints and 5 or more tender joints
• Subjects who are currently receiving oral corticosteroids must be on a dose equivalent to prednisone less than or equal to 10 mg/day at screening
• Subjects who are currently receiving non-steroidal anti-inflammatory drugs (NSAIDs), must be on a stable dose for at least 2 weeks prior to screening
• Subjects who are currently receiving DMARD therapy (including sulfasalazine, hydroxy-chloroquine and leflunomide), must be on a stable dose for at least 4 weeks prior to screening

Exclusion Criteria:

• Nursing mothers, female subjects planning on becoming pregnant, or male subjects planning a pregnancy with their spouse/partner while in the study
• ACR functional class IV
• Receipt of any investigational drug or biologic within 4 weeks of study drug initiation
• Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
• History of alcohol or drug abuse within 12 months of screening visit
• Severe comorbidities including: *History of cancer (other than resected cutaneous basal and squamous cell carcinoma, and in situ cervical cancer) within 5 years of screening visit. Documentation of disease-free state since treatment required; *Diagnosis of Class III or IV congestive heart failure (CHF) or myocardial infarction (MI) within 12 months of screening; *Unstable or stable angina pectoris; *Uncontrolled hypertension (defined as systolic blood pressure measurement of greater than 180 mm Hg or a diastolic blood pressure of greater than 110 mm Hg); *Oxygen-dependent pulmonary disease; *Known HIV-positive status or other immunodeficiency syndromes; *Chronic hepatitis B (HbsAg) or C (HCV); *Systemic lupus erythematosus (SLE); *CNS demyelinating events suggestive of multiple sclerosis; *Presence of active infection or any underlying diseases that could predispose subjects to infection (e.g., history of recurrent infections, non-healing leg ulcers, advanced or poorly controlled diabetes); *Active or prior history of tuberculosis (or known exposure).

Please refer to this study by ClinicalTrials.gov identifier  NCT00115219

Amgen Call Center      866-572-6436    mit@amgen.com

Alabama
      Research Site, Huntsville,  Alabama,  United States; Recruiting
      Research Site, Montgomery,  Alabama,  United States; Recruiting
      Research Site, Tuscaloosa,  Alabama,  United States; Recruiting
California
      Research Site, Santa Maria,  California,  United States; Recruiting
      Research Site, Victorville,  California,  United States; Recruiting
Florida
      Research Site, Jupiter,  Florida,  United States; Recruiting
      Research Site, Orlando,  Florida,  United States; Recruiting
      Research Site, South Miami,  Florida,  United States; Recruiting
      Research Site, Tamarac,  Florida,  United States; Recruiting
Illinois
      Research Site, Moline,  Illinois,  United States; Recruiting
Kentucky
      Research Site, Bowling Green,  Kentucky,  United States; Recruiting
Michigan
      Research Site, Brighton,  Michigan,  United States; Recruiting
      Research Site, Livonia,  Michigan,  United States; Recruiting
Missouri
      Research Site, Florissant,  Missouri,  United States; Recruiting
      Research Site, St. Louis,  Missouri,  United States; Recruiting
Nevada
      Research Site, Reno,  Nevada,  United States; Recruiting
New Jersey
      Research Site, Dover,  New Jersey,  United States; Recruiting
Pennsylvania
      Research Site, Bethlehem,  Pennsylvania,  United States; Recruiting
      Research Site, West Reading,  Pennsylvania,  United States; Recruiting
      Research Site, Willow Grove,  Pennsylvania,  United States; Recruiting
      Research Site, Wynnewood,  Pennsylvania,  United States; Recruiting
Tennessee
      Research Site, Memphis,  Tennessee,  United States; Recruiting
Texas
      Research Site, Dallas,  Texas,  United States; Recruiting
      Research Site, Waco,  Texas,  United States; Recruiting
Virginia
      Research Site, Arlington,  Virginia,  United States; Recruiting
Washington
      Research Site, Kirkland,  Washington,  United States; Recruiting

Study ID Numbers:  20040275
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 21, 2005
ClinicalTrials.gov Identifier:  NCT00115219
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05