Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout

• ClinicalTrials.gov Identifier: NCT03636373
• Recruitment Status: Recruiting
• First Posted: August 17, 2018
• Last Update Posted: October 9, 2019
• 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

Tracking Information

• First Submitted Date: August 13, 2018
• First Posted Date: August 17, 2018
• Last Update Posted Date: October 9, 2019
• Actual Study Start Date: May 29, 2019
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2018)

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03636373 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 15, 2018)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
• Official Title: Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4

Study Design

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

• Condition: Gout Attack

Intervention

• 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
• 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

Study Arms

• Experimental: Etanercept
  Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly
  Intervention: Drug: Etanercept
• Active Comparator: Triamcinolone acetonide
  Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously
  Intervention: Drug: Triamcinolone Acetonide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 15, 2018): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Naomi Schlesinger, MD; 732 235 8378; schlesna@rwjms.rutgers.edu

Contact: Anoja Warusawithana, BS; 732 235 6117; warusaan@rwjms.rutgers.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03636373
• Other Study ID Numbers: Pro2018000562
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Naomi Schlesinger, MD, Professor of Medicine, Rutgers, The State University of New Jersey
• Study Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Amgen

Investigators

• Principal Investigator: Naomi Schlesinger, MD; Rutgers Robert Wood Johnson Medical School

• PRS Account: Rutgers, The State University of New Jersey
• Verification Date: October 2019