Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

Exclusion Criteria

• •1. Use of intra-articular or IM corticosteroids within 14 days prior to screening;
• •2. Use of an IL-1 inhibitor, TNF inhibitor or other biologic or investigational drug within 30 days prior to screening;
• •3. History of a drug allergy to either study drug;
• •4. Diagnosis or history of:
• •1. rheumatoid arthritis (RA);
• •2. infectious/septic or other inflammatory arthritis;
• •3. alcoholic hepatitis or nonalcoholic steatohepatitis;
• •4. immunodeficiency syndromes, including Human Immunodeficiency Virus (HIV) infection;
• •5. Stage IIIb, IV, or V chronic kidney disease;
• •6. idiopathic thrombocytopenic purpura;
• •7. active, severe chronic pulmonary disease (eg, requiring oxygen therapy);
• •8. uncontrolled hypertension (≥ 200/105 mmHg);
• •9. symptomatic (New York Heart Association Class II, III, or IV) congestive heart failure;
• •10. uncontrolled diabetes Type I or II (recent blood glucose \> 300 mg/dL);
• •11. myocardial infarction, unstable cardiac arrhythmias or unstable symptomatic coronary ischemia, within the past 12 months before randomization;
• •12. history of malignancy of any organ system within the past 5 years;
• •13. multiple sclerosis or any other demyelinating disease, or;
• •14. major chronic inflammatory disease or connective tissue disease other than RA or psoriatic arthritis (PsA), including but not limited to fibromyalgia or systemic lupus erythematosus (with the exception of secondary Sjögrens syndrome, etc.);
• •5. Contraindication to IM injection;
• •6. Donation or loss of ≥400 milliliters (mL) of blood in the 8 weeks before dosing;
• •7. Any live vaccination in the 3 months before the start of the study;
• •8. Active infection (including chronic or localized infections) for which antiinfectives were indicated within 4 weeks before screening;
• •9. Any serious infection, defined as requiring hospitalization or intravenous anti-infectives, within 8 weeks before first dose of investigational product;
• •10. Prosthetic joint infection within 5 years of screening, or native joint infection within 1 year of screening;
• •11. Known alcohol addiction or dependency, daily alcohol use, or current substance use or abuse;
• •12. Positive medical history for hepatitis B or C (subjects with a history of hepatitis B vaccination without history of hepatitis B infection are allowed to enroll);
• •13. History of active tuberculosis;
• •14. Positive test for tuberculosis during screening, defined as positive Purified Protein Derivative (PPD) skin test (≥5 mm induration at 48-72 hours after test is placed), or positive Quantiferon test;
• •15. Pregnant or nursing (lactating) women
• •16. Female patients who are physiologically capable of becoming pregnant must use an acceptable method of contraception