Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
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ClinicalTrials.gov Identifier: NCT03636373 |
Recruitment Status :
Suspended
(Temporarily paused due to COVID 19 and expected to resume)
First Posted : August 17, 2018
Last Update Posted : May 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gout Attack | Drug: Etanercept Drug: Triamcinolone Acetonide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
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 |
Primary Purpose: | Treatment |
Official Title: | Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout |
Estimated Study Start Date : | June 15, 2021 |
Estimated Primary Completion Date : | June 15, 2022 |
Estimated Study Completion Date : | December 15, 2022 |

Arm | Intervention/treatment |
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Experimental: Etanercept
Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
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Drug: Etanercept
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 |
Active Comparator: Triamcinolone acetonide
Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
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Drug: Triamcinolone Acetonide
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 |
- 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 pain scale at 72 hours
- Joint pain on numeric pain scale [ Time Frame: Days 4, 7, and 14 ]Patient's assessment of joint pain intensity in the most affected baseline joint on a 0-10 pain scale, at Baseline and post-dose Days
- Patient's assessment of response to treatment [ Time Frame: Day 4, 7 and 14 ]Patient's global assessment of response to treatment
- Physician's assessment of response to treatment [ Time Frame: Post-dose days 4, 7 and 14 ]Physician's global assessment of response to treatment
- Rescue Medication [ Time Frame: Days 4, 7, 14 ]Compare the use of rescue medication
- Safety and Tolerability of Etanercept [ Time Frame: During study ]Safety and tolerability as assessed by subjects with adverse events and serious adverse events from baseline through Visit 5 safety follow-up

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key 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;
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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;
- active, severe chronic pulmonary disease (eg, requiring oxygen therapy);
- uncontrolled hypertension (≥ 200/105 mmHg);
- symptomatic (New York Heart Association Class II, III, or IV) congestive heart failure;
- uncontrolled diabetes Type I or II (recent blood glucose > 300 mg/dL);
- myocardial infarction, unstable cardiac arrhythmias or unstable symptomatic coronary ischemia, within the past 12 months before randomization;
- history of malignancy of any organ system within the past 5 years;
- multiple sclerosis or any other demyelinating disease, or;
- 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.);
- Contraindication to IM injection;
- Donation or loss of ≥400 milliliters (mL) of blood in the 8 weeks before dosing;
- Any live vaccination in the 3 months before the start of the study;
- Active infection (including chronic or localized infections) for which antiinfectives were indicated within 4 weeks before screening;
- Any serious infection, defined as requiring hospitalization or intravenous anti-infectives, within 8 weeks before first dose of investigational product;
- Prosthetic joint infection within 5 years of screening, or native joint infection within 1 year of screening;
- Known alcohol addiction or dependency, daily alcohol use, or current substance use or abuse;
- 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);
- History of active tuberculosis;
- 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;
- Pregnant or nursing (lactating) women
- Female patients who are physiologically capable of becoming pregnant must use an acceptable method of contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636373
United States, New Jersey | |
Rutgers, Robert Wood Johnson Medical School, Clinical Research Center | |
New Brunswick, New Jersey, United States, 08901 |
Principal Investigator: | Naomi Schlesinger, MD | Rutgers Robert Wood Johnson Medical School/ Rutgers RWJMS Gout center |
Responsible Party: | Naomi Schlesinger, MD, Professor of Medicine, Professor of Medicine, Rutgers, The State University of New Jersey |
ClinicalTrials.gov Identifier: | NCT03636373 |
Other Study ID Numbers: |
Pro2018000562 |
First Posted: | August 17, 2018 Key Record Dates |
Last Update Posted: | May 12, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Gout Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Etanercept Triamcinolone diacetate |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antirheumatic Agents |