Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
Condition: Gout Attack
MeSH terms: Gout
Intervention: Etanercept; Triamcinolone Acetonide
Intervention description: Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2; Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Etanercept; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be administered a single dose of etanercept 50 mg subcutaneously (SC), at the onset of an acute gout attack, or a single dose of triamcinolone acetonide 40 mg intramuscularly (IM)
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Triple
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to investigate the safety and efficacy of etanercept
      (Enbrel™; Amgen) for the treatment of an acute gout attack will be non-inferior to
      triamcinolone acetonide an FDA approved drug to treat acute gout attacks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female patients age ≥18 to ≤85 year

          2. History of established gout

          3. Onset of current acute gout attack within 4 days prior to randomization with: presence
             of any warm joint, swollen joint, pain score at rest ≥5 on the 0-10 pain scale,
             patient self-report of acute gout attack

          4. Baseline pain intensity ≥5 on a 0-10 pain scale;

          5. Tender (≥1 on a 0-4-point Likert scale) and swollen (≥1 on a 0-4-point Likert scale)
             index joint;

          6. If on urate-lowering therapy, a stable dose and regimen for at least 2 weeks prior to
             randomization, and expectance to remain on a stable dose and regimen for the duration
             of the double-blind treatment period, and;

          7. Body mass index (BMI) ≤45 kg/m2.

        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