Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
Overview
- Phase
- Phase 4
- Intervention
- Etanercept
- Conditions
- Gout Attack
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Joint Pain Intensity in the Most Affected Joint
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
The study was designed as a 14-day, two center- pilot randomized, active-controlled, double-blind, study. The study was approved by the Institutional Review Board (IRB) Pro2018000562. Patients were screened for eligibility at the time of an acute flare. Patients aged 28-55 years with an acute gout flare meeting the validated definition of flare were enrolled (12). Onset of current acute gout flare was within 3 days prior to randomization and baseline pain intensity ≥50 mm on a 0-100 mm visual analogue scale (VAS), Gout patients were defined by a confirmed diagnosis of crystal proven gout and or a score of ≥ 8 on the 2015 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Gout Classification Criteria (13). Patients recorded pain intensity in the most affected joint prior to treatment. Efficacy, including pain on a 0-100 mm VAS, and safety assessments were conducted at 24 and 72 hours, 7 and 14 days after baseline.
Investigators
Naomi Schlesinger, MD, Professor of Medicine
Professor of Medicine
Rutgers, The State University of New Jersey
Eligibility Criteria
Inclusion Criteria
- •Male or female patients age ≥18 to ≤85 year
- •History of established gout
- •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
- •Baseline pain intensity ≥5 on a 0-10 pain scale;
- •Tender (≥1 on a 0-4-point Likert scale) and swollen (≥1 on a 0-4-point Likert scale) index joint;
- •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;
- •Body mass index (BMI) ≤45 kg/m2.
Exclusion Criteria
- •Use of intra-articular or IM corticosteroids within 14 days prior to screening;
- •Use of an IL-1 inhibitor, TNF inhibitor or other biologic or investigational drug within 30 days prior to screening;
- •History of a drug allergy to either study drug;
- •Diagnosis or history of:
- •rheumatoid arthritis (RA);
- •infectious/septic or other inflammatory arthritis;
- •alcoholic hepatitis or nonalcoholic steatohepatitis;
- •immunodeficiency syndromes, including Human Immunodeficiency Virus (HIV) infection;
- •Stage IIIb, IV, or V chronic kidney disease;
- •idiopathic thrombocytopenic purpura;
Arms & Interventions
Etanercept
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
Intervention: Etanercept
Triamcinolone acetonide
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
Intervention: Triamcinolone Acetonide
Outcomes
Primary Outcomes
Joint Pain Intensity in the Most Affected Joint
Time Frame: 72 hours
Pain intensity in the most affected baseline joint measured by the numeric 0-10 Visual Analog Scale at 72 hours with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
Secondary Outcomes
- Joint Pain on Numeric Pain Scale(Baseline, Days 4, 7, and 14)
- Patient's Assessment of Response to Treatment(Day 4, 7 and 14)
- Physician's Assessment of Response to Treatment(Post-dose days 4, 7 and 14)
- Rescue Medication(Day 1 (Baseline visit - Visit 1) through Day 14 (Visit 4).)
- Safety and Tolerability of Etanercept(Day 1 (Baseline visit - Visit 1) through Day 30 (Safety follow up phone visit -Visit 5))