Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

• ClinicalTrials.gov Identifier: NCT03636373
• Recruitment Status: Suspended
• First Posted: August 17, 2018
• Last Update Posted: May 12, 2021
• Sponsor: Rutgers, The State University of New Jersey
• Collaborator: Amgen
• Information provided by (Responsible Party): Naomi Schlesinger, MD, Professor of Medicine, Rutgers, The State University of New Jersey

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gout Attack	Drug: Etanercept; Drug: Triamcinolone Acetonide	Phase 4

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Etanercept; Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly	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	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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. Patient's assessment of response to treatment [ Time Frame: Day 4, 7 and 14 ]
   Patient's global assessment of response to treatment
3. Physician's assessment of response to treatment [ Time Frame: Post-dose days 4, 7 and 14 ]
   Physician's global assessment of response to treatment
4. Rescue Medication [ Time Frame: Days 4, 7, 14 ]
   Compare the use of rescue medication
5. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New Jersey

Rutgers, Robert Wood Johnson Medical School, Clinical Research Center

New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Amgen

Investigators

• Principal Investigator: Naomi Schlesinger, MD; Rutgers Robert Wood Johnson Medical School/ Rutgers RWJMS Gout center

More Information

• 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
• 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

Additional relevant MeSH terms:

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