Gout AttackPhase 4NCT03636373
Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
A Phase 4 study testing Etanercept and Triamcinolone Acetonide in people with Gout Attack, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gout Attack
- What is being tested?
- Etanercept and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2019to 13 Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
New Brunswick, New Jersey, 08901
About this study
Official title: Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
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.
Read the 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.
- Conditions
- Gout Attack
- Being tested
- Etanercept, Triamcinolone Acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
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
Triamcinolone AcetonideDrug
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 group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Subjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly Receives: Drug: Etanercept |
| Triamcinolone acetonide | Active comparator | Subjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (5)
Joint Pain on Numeric Pain Scale
Patient's assessment of joint pain intensity in the most affected baseline joint on a numeric 0-10 Visual Analog Scale at Baseline and post-dose Days with 0 indicating no pain and 10 indicating intense pain. Higher score indicating a worse outcome.
Measured: Baseline, Days 4, 7, and 14
Patient's Assessment of Response to Treatment
Patient's global assessment of response to treatment (Likert), options are None, Poor, Acceptable, Good, Excellent
Measured: Day 4, 7 and 14
Physician's Assessment of Response to Treatment
Physician's global assessment of response to treatment None, Poor, Acceptable, Good, Excellent
Measured: Post-dose days 4, 7 and 14
Rescue Medication
Total number of patients taking rescue medication after the administration of study medication while on study.
Compare the use of rescue medication in etanercept and triamcinolone acetonide patients: for those patients having difficulty tolerating their pain, despite the treatment, were allowed to take rescue medication for pain. A paper diary was given to each patient at baseline visit to record the rescue medications.
Measured: Day 1 (Baseline visit - Visit 1) through Day 14 (Visit 4).
Safety and Tolerability of Etanercept
Safety and tolerability as assessed by subjects with adverse events and serious adverse events from baseline through Visit 5 safety follow-up
Measured: Day 1 (Baseline visit - Visit 1) through Day 30 (Safety follow up phone visit -Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start25 Oct 2019
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Why it stopped: The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gout AttackStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Naomi Schlesinger, MD, Professor of Medicine, Rutgers, The State University of New Jersey
- Investigators
- Naomi Schlesinger, MD, Principal investigator, Rutgers Robert Wood Johnson Medical School/ Rutgers RWJMS Gout center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636373
- Sponsor's protocol ID
- Pro2018000562
- Status last verified
- Oct 2023
- First submitted
- 13 Aug 2018
- Last updated
- 27 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-Initiated, Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout
- ClinicalTrials.gov ID
- NCT03636373
- Acronym / sponsor ID
- Pro2018000562
- Conditions
- Gout Attack
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor has decided to stop funding this study due to lack of enrollment during COVID-19 pandemic and decreased interest in funding investigator initiated studies pertaining to the study drug
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: EtanerceptSubjects will be administered etanercept 50 mg subcutaneously and a placebo intramuscularly |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone AcetonideSubjects will be administered triamcinolone acetonide 40 mg intramuscularly and a placebo subcutaneously |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (30 listed)
- 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:
- Contraindication to IM injection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptSubjects 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 | Etanercept |
| Triamcinolone AcetonideSubjects 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 | Drug | Triamcinolone acetonide |
Primary outcome
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.
5 secondary outcomes
Joint Pain on Numeric Pain Scale
Time frame: Baseline, Days 4, 7, and 14
Patient's Assessment of Response to Treatment
Time frame: Day 4, 7 and 14
Physician's Assessment of Response to Treatment
Time frame: Post-dose days 4, 7 and 14
Rescue Medication
Time frame: Day 1 (Baseline visit - Visit 1) through Day 14 (Visit 4).
Safety and Tolerability of Etanercept
Time frame: Day 1 (Baseline visit - Visit 1) through Day 30 (Safety follow up phone visit -Visit 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Schlesinger, MD principal investigator
Rutgers Robert Wood Johnson Medical School/ Rutgers RWJMS Gout center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept and Triamcinolone Acetonide in people with Gout Attack, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Pain Intensity in the Most Affected Joint (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.