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Enzyme
Shorter Infusion of Pegloticase + MTX for Gout
Phase 4
Waitlist Available
Research Sponsored by Horizon Therapeutics Ireland DAC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with intolerable side effects or a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview.
Presence of at least one tophus
Timeline
Screening 6 months
Treatment 6 months
Follow Up 2 months
Awards & highlights
Study Summary
This trial is testing if a gout medication is safe and works well when given with a shorter infusion time.
Who is the study for?
This trial is for adults over 18 with uncontrolled gout, defined by high uric acid levels and failure to respond to standard treatments. Participants must have had at least one gout-related lump (tophus) or two flares in the past year. They can't join if they've used certain immune-suppressing drugs, have severe kidney issues, G6PD deficiency, are pregnant or not using birth control, or have a recent history of cancer or heart problems.Check my eligibility
What is being tested?
The study tests whether pegloticase given with methotrexate (MTX) can be safely administered over a shorter infusion time in patients with stubborn gout. It aims to see if this approach is tolerable and effective when traditional medications don't work.See study design
What are the potential side effects?
Possible side effects include allergic reactions during infusion, such as rash or difficulty breathing; other potential risks may involve changes in blood pressure and sugar levels due to MTX.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My current gout medication isn't working or causes severe side effects.
Select...
I have at least one gouty nodule.
Select...
I have chronic gout.
Select...
I have gout that hasn't improved with the highest safe dose of medication.
Timeline
Screening ~ 6 months17 visits
Treatment ~ 6 months14 visits
Follow Up ~ 2 months2 visits
Screening ~ 6 months
Treatment ~ 6 months
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The incidence of participants experiencing Infusion Reactions (IRs), including anaphylaxis related to pegloticase
Secondary outcome measures
Proportion of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
The proportion of participants who experienced any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting Individual participant sUA Discontinuation Criteria.
Time to any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting individual participant sUA Discontinuation Criteria (two consecutive pre-infusion sUAs > 6mg/dL).
Side effects data
From 2015 Phase 3 trial • 139 Patients • NCT0200198719%
Rheumatoid arthritis
16%
Bronchitis
12%
Ear infection
9%
Nasopharyngitis
9%
Urinary tract infection
9%
Nausea
9%
Injection site erythema
9%
Psoriasis
9%
Back pain
7%
Neck pain
7%
Pruritus
7%
Diarrhoea
7%
Hypertension
5%
Headache
5%
Rhinitis
5%
Alanine aminotransferase increased
5%
Neutropenia
2%
Dyspepsia
2%
Vomiting
2%
Lung disorder
2%
Myocardial infarction
2%
Arthralgia
2%
Asthenia
2%
Hepatocellular injury
2%
Nephrolithiasis
2%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ MONO - All Participants
TCZ - All Participants
TCZ COMBO - All Participants
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pegloticase 60 Minute Infusion with methotrexate (MTX)Experimental Treatment1 Intervention
Pegloticase 60 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks
Group II: Pegloticase 45 Minute Infusion with methotrexate (MTX)Experimental Treatment1 Intervention
Pegloticase 45 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks
Group III: Pegloticase 30 Minute Infusion with methotrexate (MTX)Experimental Treatment1 Intervention
Pegloticase 30 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,285 Total Patients Enrolled
6 Trials studying Gout
487 Patients Enrolled for Gout
Supra Verma, MDStudy DirectorHorizon Therapeutics Ireland DAC
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Gout
50 Patients Enrolled for Gout
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had 2 or more flares of my condition in the last year.I have gout symptoms and am willing to stop my gout medication for the study.I frequently get severe bacterial infections like pneumonia.I haven't had recent serious heart issues or uncontrolled high blood pressure.I am currently undergoing treatment for my cancer.I have not been treated with pegloticase, rasburicase, or any similar drugs.I have been on long-term immunosuppressive drugs or steroids.I have gout that hasn't improved with the highest safe dose of medication.I have gout that is not managed by my current treatment.You have hyperuricemia during the screening period defined as sUA ≥6 mg/dL.I am 18 years old or older.I am 18 years old or older.I have at least one gouty nodule.I have not had cancer, except for non-dangerous skin cancer or early-stage cervical cancer, in the last 5 years.I have chronic gout.My current gout medication isn't working or causes severe side effects.I have severe kidney problems or am on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Pegloticase 30 Minute Infusion with methotrexate (MTX)
- Group 2: Pegloticase 45 Minute Infusion with methotrexate (MTX)
- Group 3: Pegloticase 60 Minute Infusion with methotrexate (MTX)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 6 Months to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Months after you stop receiving the treatment.
Gout Patient Testimony for trial: Trial Name: NCT04511702 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of participants in this clinical examination?
"Affirmative. The information accessible on clinicaltrials.gov implies that this investigation is recruiting individuals at the present time. This trial was first posted on October 2nd 2020 and has been updated as of October 18th 2022, with a goal to enlist 135 patients from 28 distinct sites."
Answered by AI
Does this experiment currently require new participants?
"Affirmative. According to clinicaltrials.gov, this research endeavour is currently searching for volunteers after being posted on October 2nd 2020 and last revised on the 18th of October 2022. The trial needs 135 individuals distributed across 28 different sites."
Answered by AI
Has Pegloticase with MTX received governmental authorization to be used therapeutically?
"Our team at Power assessed the safety of Pegloticase with MTX to be a 3, due to its status as an approved Phase 4 treatment."
Answered by AI
What medical conditions can be effectively treated with concurrent Pegloticase and MTX use?
"Pegloticase with MTX is often prescribed to individuals suffering from meningeal leukemia. However, this treatment can also be used for other maladies such as small cell lung cancer (sclc), active pauciarticular juvenile rheumatoid arthritis, and head and neck carcinoma."
Answered by AI
Are there numerous facilities in North America conducting this research?
"Currently, there are 28 medical sites offering this trial in the United States. To name a few: Medvin Clinical Research in Thousand Oaks, Arthritis Northwest in Spokane, and Prohealth Research Center Covina are all ready to recruit patients for the study."
Answered by AI
Is there precedent for the combination of Pegloticase and MTX in clinical research?
"At the moment, 220 investigations utilizing Pegloticase with MTX are in progress. 67 of these researches have advanced to phase 3 trials and can be found at 7699 locations across New york City."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Delaware
Other
Florida
What site did they apply to?
Amicis Research Center
MedPharmics, LLC
Other
Bradenton Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
2
Why did patients apply to this trial?
the pain of the gout. Only short term relief. Looking for paid studies accepting healthy adults.
PatientReceived 1 prior treatment
I have occasional flare ups even though I drink a gallon of water a day and eat healthy low.no salt diet.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Amicis Research Center: < 24 hours
- Bradenton Research Center: < 24 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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