Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
Public ClinicalTrials.gov record NCT03994731. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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])
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03994731
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 152 participants
Conditions and interventions
Conditions
Interventions
- Pegloticase Biological
- methotrexate Drug
- placebo Drug
- folic acid Dietary Supplement
- gout flare prophylaxis regimen Drug
- fexofenadine Drug
- acetaminophen Drug
- methylprednisolone Drug
Biological · Drug · Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 13, 2019 (Actual)
- Primary completion
- Mar 17, 2021 (Actual)
- Completion
- Apr 11, 2022 (Actual)
- Last update posted
- Jun 26, 2024
2019 – 2022
United States locations
- U.S. sites
- 60
- U.S. states
- 22
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| Orthopedic Physicians Alaska | Anchorage | Alaska | 99508 | — |
| Arizona Arthritis and Rheumatology Research, PLLC - Flagstaff | Flagstaff | Arizona | 86001 | — |
| Arizona Arthritis and Rheumatology Research, PLLC-West | Glendale | Arizona | 85306 | — |
| Arizona Arthritis and Rheumatology Research, PLLC-East | Mesa | Arizona | 85210 | — |
| Applied Research Center of Arkansas, Inc | Little Rock | Arkansas | 72212 | — |
| TriWest Research Associates | El Cajon | California | 92020 | — |
| Advanced Investigative Medicine, Inc. | Hawthorne | California | 90250 | — |
| Axis Clinical Trials | Los Angeles | California | 90036 | — |
| ACRC Studies | Poway | California | 92064 | — |
| ClinEdge Sierra Rheumatology, Inc. | Roseville | California | 95661 | — |
| East Bay Rheumatology Medical Group, Inc. | San Leandro | California | 94578 | — |
| Providence St. John's Health Clinic | Santa Monica | California | 90404 | — |
| Medvin Clinical Research | Tujunga | California | 91042 | — |
| San Fernando Valley Health Institute | Van Nuys | California | 91405 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| University of Colorado Division of Rheumatology | Aurora | Colorado | 80045 | — |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | — |
| Avail Clinical Research | DeLand | Florida | 32720 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| Omega Research Maitland | Orlando | Florida | 32808 | — |
| DMI Research | Pinellas Park | Florida | 33782 | — |
| Napa Research Center | Pompano Beach | Florida | 33064 | — |
| GCP Clinical Research | Tampa | Florida | 33609 | — |
| Florida Medical Clinic, LLC | Zephyrhills | Florida | 33542 | — |
| St. Luke's Clinic - Rheumatology | Meridian | Idaho | 83642 | — |
| MD Medical Research | Oxon Hill | Maryland | 20745 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| Infusion Associates | Grand Rapids | Michigan | 49525 | — |
| Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | 48081 | — |
| Benefis Hospital | Great Falls | Montana | 59405 | — |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | — |
| Santa Fe Rheumatology | Santa Fe | New Mexico | 87505 | — |
| Long Island Arthritis & Osteoporosis Care | Babylon | New York | 11702 | — |
| Buffalo Rheumatology and Medicine | Orchard Park | New York | 14127 | — |
| NorthEast Rheumatology/Atrium Health | Concord | North Carolina | 28025 | — |
| NorthEast Rheumatology | Concord | North Carolina | 28025 | — |
| Medication Management, LLC | Greensboro | North Carolina | 27408 | — |
| ClinEdge PMG Research of Hickory, LLC | Hickory | North Carolina | 28602 | — |
| ClinEdge PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | — |
| Shelby Clinical Research, LLC | Shelby | North Carolina | 28150 | — |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| Premier Clinical/STAT Research | Dayton | Ohio | 45417 | — |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | — |
| Clinical Research Source Inc. | Perrysburg | Ohio | 43551 | — |
| Premier Clinical/STAT Research - Springboro | Springboro | Ohio | 45066 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Piedmont Arthritis Clinic | Greenville | South Carolina | 29601 | — |
| Articularis Healthcare Group | Summerville | South Carolina | 29486 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Ramesh C. Gupta, M.D. | Memphis | Tennessee | 38119 | — |
| Diagnostic and Interventional Nephrology Of Houston | Houston | Texas | 77004 | — |
| Research Consultants - Frostwood | Houston | Texas | 77024 | — |
| Research Consultants - Astoria | Houston | Texas | 77089 | — |
| Arthritis Clinic of Central Texas | San Marcos | Texas | 78666 | — |
| Arthritis & Osteoporosis Clinic - Waco | Waco | Texas | 76710 | — |
| Clear Lake Specialties | Webster | Texas | 77598 | — |
| Western Washington Arthritis Clinic | Bothell | Washington | 98021 | — |
| Arthritis Northwest | Spokane | Washington | 99204 | — |
| Rheumatic Disease Center | Glendale | Wisconsin | 53219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03994731, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03994731 live on ClinicalTrials.gov.