Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

NCT03636373 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro2018000562
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout Attack

Outcome Measures

Primary Outcomes (1)

• Joint Pain Intensity in the Most Affected Joint

  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.

  72 hours

Secondary Outcomes (5)

• 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)

Study Arms (2)

Etanercept

EXPERIMENTAL

Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly

Drug: Etanercept

Triamcinolone acetonide

ACTIVE COMPARATOR

Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously

Drug: Triamcinolone Acetonide

Interventions

Etanercept DRUG

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

Etanercept

Triamcinolone Acetonide DRUG

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

Triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Amgen: collaborator

Study Sites (1)

Rutgers, Robert Wood Johnson Medical School, Clinical Research Center

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Interventions

Etanercept; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed;

Results Point of Contact

• Title: Naomi Schlesinger, MD
• Organization: Rutgers, The State University of New Jersey

Naomi.Schlesinger@hsc.utah.edu

732 235 6117

Study Officials

• Naomi Schlesinger, MD

  Rutgers Robert Wood Johnson Medical School/ Rutgers RWJMS Gout center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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)

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: October 25, 2019
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)