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GoutPhase 4MIRROR RCTNCT03994731

Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout

A Phase 4 study testing Pegloticase, methotrexate and folic acid in people with Gout, run by Amgen at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-administered with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout
What is being tested?
Pegloticase, methotrexate and folic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
60 sitesUnited States
Study dates
13 Jun 2019to 11 Apr 2022
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 years and older
  • 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 study.
  • Adult men or women ≥18 years of age.
  • Uncontrolled gout, defined as meeting the following criteria:
  • Hyperuricemia during the screening period defined as sUA ≥7 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
  • Willing to discontinue any oral urate lowering therapy for at least 7 days prior to MTX dosing at Week -6 and remain off when receiving pegloticase infusions.
  • 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 -6; subjects must agree to use 2 reliable forms of contraception during the study, one of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started ≥1 full cycle prior to Week -6 (start of MTX) and continue for 30 days after the last dose of pegloticase, or at least one ovulatory cycle after the last dose of MTX or placebo for MTX (whichever is the longest duration after the last dose of pegloticase or MTX or placebo for 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 study, beginning with the initiation of MTX at Week -6 and continuing and for at least 3 months after the last dose of MTX or placebo for MTX.
  • Able to tolerate MTX 15 mg orally for 2 weeks (Week -6 through Week -4) prior to randomization.

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 Week -6 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 ribonucleic acid (RNA) positivity.
  • Known history of Human Immunodeficiency Virus (HIV) positivity.
  • Glucose-6-phosphate dehydrogenase deficiency (tested at the Screening Visit).
  • 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 Randomization at Week -4.
  • 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 -6 or plans to take an investigational drug during the study.
  • Liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > upper limit of normal (ULN) or albumin < the lower limit of normal (LLN) at the Screening Visit).
  • Chronic liver disease.
  • White blood cell count < 4,000/µL, hematocrit < 32 percent, or platelet count < 75,000/µL.
  • Currently receiving systemic or radiologic treatment for ongoing 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 study, 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 study.
  • 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

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Orthopedic Physicians Alaska

    Anchorage, Alaska, 99508

  • University of Colorado Division of Rheumatology

    Aurora, Colorado, 80045

  • Long Island Arthritis & Osteoporosis Care

    Babylon, New York, 11702

  • University of Alabama

    Birmingham, Alabama, 35294

  • Western Washington Arthritis Clinic

    Bothell, Washington, 98021

  • NorthEast Rheumatology/Atrium Health

    Concord, North Carolina, 28025

  • NorthEast Rheumatology

    Concord, North Carolina, 28025

  • Premier Clinical/STAT Research

    Dayton, Ohio, 45417

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Prohealth Research Center

    Doral, Florida, 33166

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • TriWest Research Associates

    El Cajon, California, 92020

  • Arizona Arthritis and Rheumatology Research, PLLC - Flagstaff

    Flagstaff, Arizona, 86001

  • Arizona Arthritis and Rheumatology Research, PLLC-West

    Glendale, Arizona, 85306

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53219

  • Infusion Associates

    Grand Rapids, Michigan, 49525

  • Benefis Hospital

    Great Falls, Montana, 59405

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • Piedmont Arthritis Clinic

    Greenville, South Carolina, 29601

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California, 90250

  • ClinEdge PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602

  • Diagnostic and Interventional Nephrology Of Houston

    Houston, Texas, 77004

  • Research Consultants - Frostwood

    Houston, Texas, 77024

  • Research Consultants - Astoria

    Houston, Texas, 77089

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • Applied Research Center of Arkansas, Inc

    Little Rock, Arkansas, 72212

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Ramesh C. Gupta, M.D.

    Memphis, Tennessee, 38119

  • St. Luke's Clinic - Rheumatology

    Meridian, Idaho, 83642

  • Arizona Arthritis and Rheumatology Research, PLLC-East

    Mesa, Arizona, 85210

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Buffalo Rheumatology and Medicine

    Orchard Park, New York, 14127

  • Omega Research Maitland

    Orlando, Florida, 32808

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Clinical Research Source Inc.

    Perrysburg, Ohio, 43551

  • DMI Research

    Pinellas Park, Florida, 33782

  • Napa Research Center

    Pompano Beach, Florida, 33064

  • ACRC Studies

    Poway, California, 92064

  • ClinEdge Sierra Rheumatology, Inc.

    Roseville, California, 95661

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081

  • ClinEdge PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • East Bay Rheumatology Medical Group, Inc.

    San Leandro, California, 94578

  • Arthritis Clinic of Central Texas

    San Marcos, Texas, 78666

  • Santa Fe Rheumatology

    Santa Fe, New Mexico, 87505

  • Providence St. John's Health Clinic

    Santa Monica, California, 90404

  • Shelby Clinical Research, LLC

    Shelby, North Carolina, 28150

  • Arthritis Northwest

    Spokane, Washington, 99204

  • Premier Clinical/STAT Research - Springboro

    Springboro, Ohio, 45066

  • Articularis Healthcare Group

    Summerville, South Carolina, 29486

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Medvin Clinical Research

    Tujunga, California, 91042

  • San Fernando Valley Health Institute

    Van Nuys, California, 91405

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Arthritis & Osteoporosis Clinic - Waco

    Waco, Texas, 76710

  • Clear Lake Specialties

    Webster, Texas, 77598

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Florida Medical Clinic, LLC

    Zephyrhills, Florida, 33542

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT])

The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-administered with MTX to pegloticase co-administered with placebo for MTX in adults with uncontrolled gout.

Read the detailed description

Study acquired from Horizon in 2024.

Conditions
Gout
Being tested
Pegloticase, methotrexate, placebo, folic acid, gout flare prophylaxis regimen
Keywords
gout, 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

    Also called KRYSTEXXA®

    IV pegloticase 8 mg Q2W

  • methotrexateDrug

    Also called MTX

    Oral MTX 15 mg weekly

  • placeboDrug

    Oral placebo for MTX

  • folic acidDietary supplement

    Folic acid 1 mg orally every day beginning at Week -6 until prior to the Week 52 Visit.

  • gout flare prophylaxis regimenDrug

    Prior to beginning the Pegloticase + IMM Period, participants must have been taking at least 1 protocol-standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day) for ≥ 1 week before the first dose of pegloticase and to continue flare prophylaxis per American College of Rheumatology guidelines [Khanna D et al. 2012] for the greater of 1) 6 months, 2) 3 months after achieving target serum urate (sUA < 6 mg/dL) for participants with no tophi detected on physical exam, or 3) 6 months after achieving target serum urate (sUA < 5 mg/dL) for participants with one or more tophi detected on initial physical exam that then resolved.

  • fexofenadineDrug

    For IR prophylaxis, fexofenadine (180 mg orally) taken the day before each infusion and on the morning of each infusion.

  • acetaminophenDrug

    For IR prophylaxis, acetaminophen (1000 mg orally) taken the morning of each infusion.

  • methylprednisoloneDrug

    For IR prophylaxis, methylprednisolone (125 mg IV) given over an infusion duration between 10 - 30 minutes, immediately prior to each infusion.

Study groups in NCT03994731
Study groupRoleWhat they receive
Pegloticase + MTXExperimentalFollowing the MTX Tolerability Assessment Period (Week -6 until the Week -4 visit, in which participants take oral MTX 15 mg weekly), participants tolerating MTX are randomized to receive blinded oral MTX 15 mg weekly during the Run-in Period (from Week -4 to Day 1). During the Pegloticase + Immunomodulator (IMM) Period, in addition to oral 15 mg MTX, participants receive intravenous (IV) pegloticase 8 mg administered every 2 weeks (Q2W) for a total of 26 infusions from Day 1 through the Week 50 Visit. Per protocol, participants are also required to take folic acid, at least one protocol standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤10 mg/day), and a regimen of fexofenadine, acetaminophen, and methylprednisolone for infusion reaction (IR) prophylaxis.
Receives: Biological: Pegloticase; Drug: methotrexate; Dietary Supplement: folic acid; Drug: gout flare prophylaxis regimen; Drug: fexofenadine; Drug: acetaminophen; Drug: methylprednisolone
Pegloticase + PlaceboPlacebo comparatorFollowing the MTX Tolerability Assessment Period (Week -6 until the Week -4 visit, in which participants take oral MTX 15 mg weekly), participants tolerating MTX are randomized to receive blinded oral placebo for MTX weekly during the Run-in Period (from Week -4 to Day 1). During the Pegloticase + IMM Period, in addition to oral placebo for MTX, all participants receive IV pegloticase 8 mg administered Q2W for a total of 26 infusions from Day 1 through the Week 50 Visit. Per protocol, participants are also required to take folic acid, at least one protocol standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤10 mg/day), and a regimen of fexofenadine, acetaminophen, and methylprednisolone for IR prophylaxis.
Receives: Biological: Pegloticase; Drug: methotrexate; Drug: placebo; Dietary Supplement: folic acid; Drug: gout flare prophylaxis regimen; Drug: fexofenadine; Drug: acetaminophen; Drug: methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of 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. Month 6 includes pre- and post-infusion sUA assessments at Weeks 20 and 22, non-infusion sUA at Weeks 21 and 23, pre-infusion sUA at Week 24 and any unscheduled sUA between Week 20 and Week 24. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders.

    Measured: Month 6 (Weeks 20, 21, 22, 23 and 24)

Secondary outcomes (5)

  1. Percentage of sUA (sUA < 6 mg/dL) Responders During Month 12

    Responders are defined as participants achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12 (Weeks 48, 50 and 52). Month 12 includes pre- and post-infusion sUA Weeks 48 and 50, pre-infusion sUA at Week 52, and any unscheduled sUA assessments done at unscheduled visits between Week 48 and 52. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders.

    Measured: Month 12 (Weeks 48, 50 and 52)

  2. Percentage of Participants With Complete Resolution of ≥ 1 Tophi at Week 52

    Percentage of participants with complete resolution of ≥ 1 tophi (using digital photography) at Week 52 in participants with tophi at baseline. Participants with resolution of ≥ 1 tophi at a visit are participants with resolution of ≥ 1 tophi at the visit (i.e. have complete response), and no progressive disease for any other tophi.

    Measured: Baseline, Week 52

  3. Mean Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52

    HAQ-DI is a self-report functional status instrument that is filled out by the participant and measures disability over the past week via 20 questions relating to 8 domains of function: dressing, grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. The HAQ-DI ranges from 0 to 3 with higher values indicating higher disability. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values.

    Measured: Baseline, Week 52

  4. Mean Change From Baseline HAQ Pain Score at Week 52

    The HAQ-Pain score rates the participant's pain over the past week from 0 to 100 with 0 = no pain and 100 = severe pain. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values.

    Measured: Baseline, Week 52

  5. Mean Change From Baseline in HAQ Health Score at Week 52

    The HAQ health scale is a self-reported measure of overall health. Participants are asked to rate how they are doing, considering all the ways arthritis affects them, on a scale of 0 to 100, where 0 represents very well and 100 represents very poor. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values.

    Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start13 Jun 2019
  3. Primary completion17 Mar 2021
  4. Study completion11 Apr 2022

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03994731
Sponsor's protocol ID
HZNP-KRY-202
Acronym
MIRROR RCT
Status last verified
Jun 2024
First submitted
19 Jun 2019
Last updated
26 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Domingues V, Abdellatif A, Woods A, Yang Q, Weinblatt ME, Ji J, Marder B, LaMoreaux B. Tolerance of methotrexate co-administered with pegloticase in patients with uncontrolled gout: overview of the findings from the mirror RCT. Expert Opin Drug Saf. 2026 Sep 23. doi: 10.1080/14740338.2026.2735075. Online ahead of print.

    PubMed 42775939

  • Botson J, Obermeyer K, LaMoreaux B, Padnick-Silver L, Verma S, Weinblatt ME, Peterson J. Quality of life and clinical gout assessments during pegloticase with and without methotrexate co-therapy: MIRROR randomized controlled trial exploratory findings. Rheumatol Adv Pract. 2024 Nov 29;8(4):rkae145. doi: 10.1093/rap/rkae145. eCollection 2024.

    PubMed 39678124

  • Dalbeth N, Botson J, Saag K, Kumar A, Padnick-Silver L, LaMoreaux B, Becce F. Monosodium urate crystal depletion and bone erosion remodeling during pegloticase treatment in patients with uncontrolled gout: Exploratory dual-energy computed tomography findings from MIRROR RCT. Joint Bone Spine. 2024 Jul;91(4):105715. doi: 10.1016/j.jbspin.2024.105715. Epub 2024 Mar 4.

    PubMed 38447697

  • Botson JK, Saag K, Peterson J, Parikh N, Ong S, La D, LoCicero K, Obermeyer K, Xin Y, Chamberlain J, LaMoreaux B, Verma S, Sainati S, Grewal S, Majjhoo A, Tesser JRP, Weinblatt ME. A Randomized, Placebo-Controlled Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase: Primary Efficacy and Safety Findings. Arthritis Rheumatol. 2023 Feb;75(2):293-304. doi: 10.1002/art.42335. Epub 2022 Dec 16.

    PubMed 36099211

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pegloticase, methotrexate and folic acid in people with Gout, run by Amgen at 60 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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. Some participants in this study may receive a placebo. 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 16 May 2022). 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 Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6 (time frame: Month 6 (Weeks 20, 21, 22, 23 and 24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994731, which also lists 4 linked publications.

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 26 Jun 2024.

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