Uncontrolled GoutPhase 4FORWARD OLNCT04762498
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
A Phase 4 study testing Pegloticase and Methotrexate (MTX) in people with Uncontrolled Gout and Chronic Gout, run by Amgen at 12 sites in United States.
Trial summary
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uncontrolled Gout, Chronic Gout
- What is being tested?
- Pegloticase and Methotrexate (MTX)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 12 sitesUnited States
- Study dates
- 26 Jan 2021to 20 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give informed consent.
- Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Adult men or women ≥18 and <80 years of age.
- Uncontrolled gout, defined as meeting the following criteria:
- Hyperuricemia during the screening period defined as sUA ≥6 mg/dL, and;
- Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview, and;
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- Symptoms of gout including at least 1 of the following:
- Presence of at least one tophus
- Recurrent flares defined as 2 or more flares in the past 12 months prior to screening
- Presence of chronic gouty arthritis as evidenced by either clinical signs consistent with chronic synovitis on clinical examination or the presence of typical gouty erosion(s) on hand and/or foot X-rays
- Willing to discontinue any oral urate lowering therapy for at least 7 days prior to MTX dosing at Week -4 and remain off while receiving pegloticase treatments.
- Women of childbearing potential (including those with an onset of menopause <2 years prior to screening, non-therapy-induced amenorrhea for <12 months prior to screening, or not surgically sterile [absence of ovaries and/or uterus]) must have negative serum/urine pregnancy tests during Screening and Week -4; subjects must agree to use 2 reliable forms of contraception during the trial, one of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started ≥1 full cycle prior to Week -4 (start of MTX) and continue for 4 weeks/30 days after the last dose of pegloticase, or at least one ovulatory cycle after the last dose of MTX (whichever is the longest duration after the last dose of pegloticase or MTX). Highly effective contraceptive methods (with a failure rate <1% per year), when used consistently and correctly, include implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or vasectomized partner.
- Men who are not vasectomized must agree to use appropriate contraception so as to not impregnate a female partner of reproductive potential during the trial, beginning with the initiation of MTX at Week -4 and continuing and for at least 3 months after the last dose of MTX.
- Able to tolerate MTX 15 mg orally for 4 weeks (Week -4 through Day 1) prior to enrollment.
Who cannot join
- Weight >160 kg (352 pounds) at Screening.
- Any serious acute bacterial infection, unless treated and completely resolved with antibiotics at least 2 weeks prior to the Day 1 Visit.
- Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
- Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (3 months or longer) would also meet exclusion criteria.
- History of any transplant surgery requiring maintenance immunosuppressive therapy.
- Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity.
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- Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative.
- Known history of Human Immunodeficiency Virus (HIV) positivity.
- Glucose-6-phosphate dehydrogenase deficiency (tested at the Screening Visit centrally or locally).
- Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m^2 or currently on dialysis.
- Non-compensated congestive heart failure or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina), or uncontrolled blood pressure (>160/100 mmHg) prior to enrollment at Day 1.
- Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner, or not on an effective form of birth control, as determined by the Investigator.
- Prior treatment with pegloticase, another recombinant uricase (rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug.
- Known allergy to pegylated products or history of anaphylactic reaction to a recombinant protein or porcine product.
- Contraindication to MTX treatment or MTX treatment considered inappropriate.
- Known intolerance to MTX.
- Receipt of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to MTX administration at Week -4 or plans to take an investigational drug during the trial.
- Liver transaminase levels (AST or ALT) > 1.25 X upper limit of normal (ULN) or albumin < the lower limit of normal (LLN) at the Screening Visit.
- Chronic liver disease.
- White blood cell count <4000/µl, hematocrit <32 percent, or platelet count <75,000/µl.
- Currently receiving systemic or radiologic treatment for ongoing cancer, excluding non-melanoma skin cancer.
- History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix.
- Diagnosis of osteomyelitis.
- Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
- Unsuitable candidate for the trial, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the trial.
- Alcohol use in excess of 3 alcoholic beverages per week.
- A known intolerance to all protocol standard gout flare prophylaxis regimens (i.e., subject must be able to tolerate at least one: colchicine and/or non-steroidal anti-inflammatory drugs and/or low dose prednisone ≤10 mg/day).
- Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Orthopedic Physicians Alaska
Anchorage, Alaska, 99508
Arthritis Clinic: Western Washington Medical Group
Bothell, Washington, 98021
ProHealth Research Center
Doral, Florida, 33166
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306
Biopharma Informatic, LLC
Houston, Texas, 77043
Napa Research Center
Pompano Beach, Florida, 33064
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, 94578
Shelby Clinical Research, LLC
Shelby, North Carolina, 28150
Arthritis Northwest PLLC
Spokane, Washington, 99204
GCP Clinical Research
Tampa, Florida, 33064
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: A Phase 4, Open-Label, Multicenter, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Trial of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks With Co-Administration of Weekly Doses of Methotrexate in Patients With Uncontrolled Refractory Gout (FORWARD Open-Label [OL] Trial)
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is to identify an appropriate dose to be administered every 4 weeks to be used for future clinical trials for patients with chronic gout that does not adequately respond to conventional therapy.
Read the detailed description
The primary objective is to choose a dose for further investigation by assessing the effect of up to 2 dose levels of pegloticase administered IV Q4 weeks, co-administered with weekly doses of oral MTX, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6 and the duration of sUA to < 6 mg/dL over 24 week treatment period in adult participants with chronic gout refractory to conventional therapy.
Acquired from Horizon in 2024.
- Conditions
- Uncontrolled Gout, Chronic Gout
- Being tested
- Pegloticase, Methotrexate (MTX)
- Keywords
- Gout, KRYSTEXXA, Pegloticase, Methotrexate, Uncontrolled gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegloticaseBiological
IV dose of pegloticase q4 weeks co-administered with weekly oral methotrexate
Methotrexate (MTX)Drug
15 mg oral dose methotrexate administered weekly
| Study group | Role | What they receive |
|---|---|---|
| Pegloticase 16mg cohort | Experimental | 16 mg IV dose of pegloticase q4 weeks with 15 mg methotrexate (MTX) weekly Receives: Biological: Pegloticase; Drug: Methotrexate (MTX) |
| Pegloticase 24/32mg cohort | Experimental | 24 to 32 mg IV dose of pegloticase q4 weeks with 15 mg MTX weekly Receives: Biological: Pegloticase; Drug: Methotrexate (MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Were Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
Responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 6. Participants meeting the sUA discontinuation criteria (pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 1 Visit) were counted as non-responders.
Measured: Month 6 (Weeks 20, 21, 22, 23, and 24)
Time to First sUA ≥6 mg/dL After First Achieving sUA <6 mg/dL, From the First Pegloticase Infusion Until Week 24
The number of participants who had pre-Infusion sUA ≥ 6 mg/dL post-day 1 pegloticase infusion were included in this analysis.
The date of the first pre-infusion sUA ≥ 6 mg/dL was the event date. Participants who did not have the event were censored at the date of the last collected pre-infusion sample with non-missing sUA result. Participants who never achieved sUA < 6 mg/dL were excluded from the analysis.
Measured: Day 1 to Week 24
Secondary outcomes (8)
Maximum Concentration (Cmax) of Pegloticase
Noncompartmental Pharmacokinetic (PK) parameters of pegloticase were estimated using concentration data after the first dose (including Week 4 predose concentration data) using Phoenix WinNonlin® software. The linear/log trapezoidal rule was used in conjunction with the appropriate noncompartmental model, with input values for dose level, dosing time, serum concentration, and corresponding real-time values, based on drug dosing times whenever possible.
Below limit of quantification (BLQ) values prior to the first quantifiable concentration were set to 0; BLQ values at all other time points were set to half the lower limit of quantification (LLOQ) (0.025 µg/mL).
Measured: Post infusion on Day 1, at Weeks 1, 2, 3 and pre-dose at Week 4
Area Under the Concentration- Time Curve From Time 0 to Week 4 Predose of Pegloticase
Noncompartmental PK parameters of pegloticase were estimated using concentration data after the first dose (including Week 4 predose concentration data) using Phoenix WinNonlin® software. The linear/log trapezoidal rule was used in conjunction with the appropriate noncompartmental model, with input values for dose level, dosing time, serum concentration, and corresponding real-time values, based on drug dosing times whenever possible.
BLQ values prior to the first quantifiable concentration were set to 0; BLQ values at all other time points were set to half LLOQ (0.025 µg/mL).
Measured: Post infusion on Day 1, at Weeks 1, 2, 3 and pre-dose at Week 4
Trough Serum Concentration (Ctrough) of Pegloticase at Week 24 Pre-dose
Blood samples were collected for measurement of serum concentrations of pegloticase. The median concentration of pegloticase taken at Week 24 pre-dose was reported as the Ctrough concentration at Week 24.
Measured: Week 24 Pre-dose
Percentage of Participants With Pre-infusion sUA <6 mg/dL at Each Scheduled Visit
The percentage of participants with pre-infusion sUA <6 mg/dL at each scheduled infusion visit, regardless of treatment status, was presented.
Measured: Pre-infusion on Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44
Area Under the sUA Concentration vs Time Curve From Day 1 to Week 24 and Day 1 to Week 48
The AUC from Day 1 to Week 24 and from Day 1 to Week 48 was calculated as time-adjusted AUC derived using the trapezoidal rule divided by the number of total days in the given period. The AUC from Day 1 to Week 48 was only calculated for participants who continued in the optional treatment period from Week 24 to Week 48.
Measured: Day 1 to Week 24 and Day 1 to Week 48
Percentage of Time Participants Sustained sUA < 6 mg/dL From Day 1 to Week 24 or Day 1 to Week 48
The percentage of time that participants sustained sUA < 6 mg/dL was derived using linear interpolation across all observed data points between Day 1 and the end of each analysis period. The percentage of time during a given period is the time that sUA < 6 mg/dL divided by the total time from the first to the last scheduled visit in the given period.
Measured: Day 1 to Week 24 and Day 1 to Week 48
Percentage of Participants With Anti-uricase Antibodies at Each Scheduled Visit
Pegloticase immunogenicity was assessed by incidence of anti-poly (Ethylene Glycol) (PEG) and anti-uricase immunoglobulin G (IgG) antibodies.
The percentage of participants who were treatment-emergent anti-drug antibody (ADA) positive is presented below. Participants were considered treatment-emergent ADA positive if they were ADA negative at the data collection timepoint of Day 1 (Baseline) and ADA positive at one of the specified post-dose timepoints.
Measured: Day 1 (Baseline) and Weeks 2, 4, 8, 16, 24, 36 and 48
Percentage of Participants With Anti-PEG Antibodies at Each Scheduled Visit
Pegloticase immunogenicity was assessed by incidence of anti-PEG and anti-uricase IgG antibodies.
The percentage of participants who were treatment-emergent ADA positive is presented below. Participants were considered treatment-emergent ADA positive if they were ADA negative at the data collection timepoint of Day 1 (Baseline) and ADA positive at one of the specified post-dose timepoints.
Measured: Day 1 (Baseline) and Weeks 2, 4, 8, 16, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start26 Jan 2021
- Primary completion18 May 2023
- Study completion20 Dec 2023
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 Uncontrolled GoutStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Screening period up to 35 days, followed by 4-week methotrexate (MTX) tolerability run-in. Treatment consists of pegloticase IV Q4 Wks dose for a total of 6 infusions (24 Weeks) with co-administered weekly oral MTX. Optional extension treatment (24-48 weeks) will be available for 6 more infusions (total of 12). Study will consist of Cohort 1: 16 mg pegloticase, co-administered with weekly doses of oral MTX; and, potential Cohort 2: 24 to 32 mg pegloticase, co-administered with weekly doses of oral MTX and/or potential infusion duration reduction to 60 min.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, AmgenSupra Verma, MD, Study director, Horizon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762498
- Sponsor's protocol ID
- HZNP-KRY-408
- Acronym
- FORWARD OL
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2021
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label, Multicenter, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Trial of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks With Co-Administration of Weekly Doses of Methotrexate in Patients With Uncontrolled Refractory Gout (FORWARD Open-Label [OL] Trial)
- ClinicalTrials.gov ID
- NCT04762498
- Acronym / sponsor ID
- FORWARD OL / HZNP-KRY-408
- Conditions
- Uncontrolled Gout, Chronic Gout
- Keywords
- Gout, KRYSTEXXA, Pegloticase, Methotrexate, Uncontrolled gout
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is to identify an appropriate dose to be administered every 4 weeks to be used for future clinical trials for patients with chronic gout that does not adequately respond to conventional therapy.
Detailed description
The primary objective is to choose a dose for further investigation by assessing the effect of up to 2 dose levels of pegloticase administered IV Q4 weeks, co-administered with weekly doses of oral MTX, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6 and the duration of sUA to < 6 mg/dL over 24 week treatment period in adult participants with chronic gout refractory to conventional therapy.
Acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Screening period up to 35 days, followed by 4-week methotrexate (MTX) tolerability run-in. Treatment consists of pegloticase IV Q4 Wks dose for a total of 6 infusions (24 Weeks) with co-administered weekly oral MTX. Optional extension treatment (24-48 weeks) will be available for 6 more infusions (total of 12). Study will consist of Cohort 1: 16 mg pegloticase, co-administered with weekly doses of oral MTX; and, potential Cohort 2: 24 to 32 mg pegloticase, co-administered with weekly doses of oral MTX and/or potential infusion duration reduction to 60 min.
| Arm | Type | Receives |
|---|---|---|
| Pegloticase 16mg cohort | Experimental | Biological: Pegloticase, Drug: Methotrexate (MTX)16 mg IV dose of pegloticase q4 weeks with 15 mg methotrexate (MTX) weekly |
| Pegloticase 24/32mg cohort | Experimental | Biological: Pegloticase, Drug: Methotrexate (MTX)24 to 32 mg IV dose of pegloticase q4 weeks with 15 mg MTX weekly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to give informed consent.
- Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Adult men or women ≥18 and <80 years of age.
- Uncontrolled gout, defined as meeting the following criteria:
- Willing to discontinue any oral urate lowering therapy for at least 7 days prior to MTX dosing at Week -4 and remain off while receiving pegloticase treatments.
Key exclusion criteria (28 listed)
- Weight >160 kg (352 pounds) at Screening.
- Any serious acute bacterial infection, unless treated and completely resolved with antibiotics at least 2 weeks prior to the Day 1 Visit.
- Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
- Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (3 months or longer) would also meet exclusion criteria.
- History of any transplant surgery requiring maintenance immunosuppressive therapy.
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 |
|---|---|---|
| PegloticaseIV dose of pegloticase q4 weeks co-administered with weekly oral methotrexate | Biological | Pegloticase 16mg cohort, Pegloticase 24/32mg cohort |
| Methotrexate (MTX)15 mg oral dose methotrexate administered weekly | Drug | Pegloticase 16mg cohort, Pegloticase 24/32mg cohort |
Primary outcome
Percentage of Participants Who Were Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
Time frame: Month 6 (Weeks 20, 21, 22, 23, and 24)
Responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 6. Participants meeting the sUA discontinuation criteria (pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 1 Visit) were counted as non-responders.
Time to First sUA ≥6 mg/dL After First Achieving sUA <6 mg/dL, From the First Pegloticase Infusion Until Week 24
Time frame: Day 1 to Week 24
The number of participants who had pre-Infusion sUA ≥ 6 mg/dL post-day 1 pegloticase infusion were included in this analysis. The date of the first pre-infusion sUA ≥ 6 mg/dL was the event date. Participants who did not have the event were censored at the date of the last collected pre-infusion sample with non-missing sUA result. Participants who never achieved sUA < 6 mg/dL were excluded from the analysis.
8 secondary outcomes
Maximum Concentration (Cmax) of Pegloticase
Time frame: Post infusion on Day 1, at Weeks 1, 2, 3 and pre-dose at Week 4
Area Under the Concentration- Time Curve From Time 0 to Week 4 Predose of Pegloticase
Time frame: Post infusion on Day 1, at Weeks 1, 2, 3 and pre-dose at Week 4
Trough Serum Concentration (Ctrough) of Pegloticase at Week 24 Pre-dose
Time frame: Week 24 Pre-dose
Percentage of Participants With Pre-infusion sUA <6 mg/dL at Each Scheduled Visit
Time frame: Pre-infusion on Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44
Area Under the sUA Concentration vs Time Curve From Day 1 to Week 24 and Day 1 to Week 48
Time frame: Day 1 to Week 24 and Day 1 to Week 48
Percentage of Time Participants Sustained sUA < 6 mg/dL From Day 1 to Week 24 or Day 1 to Week 48
Time frame: Day 1 to Week 24 and Day 1 to Week 48
Percentage of Participants With Anti-uricase Antibodies at Each Scheduled Visit
Time frame: Day 1 (Baseline) and Weeks 2, 4, 8, 16, 24, 36 and 48
Percentage of Participants With Anti-PEG Antibodies at Each Scheduled Visit
Time frame: Day 1 (Baseline) and Weeks 2, 4, 8, 16, 24, 36 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
MD study director
Amgen
Supra Verma, MD study director
Horizon Therapeutics
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegloticase and Methotrexate (MTX) in people with Uncontrolled Gout and Chronic Gout, run by Amgen at 12 sites 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 14 inclusion and 28 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: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 19 May 2026). 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?
Percentage of Participants Who Were Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6 (time frame: Month 6 (Weeks 20, 21, 22, 23, and 24)). The study lists 2 primary outcomes in all. 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 19 May 2026.