Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
Public ClinicalTrials.gov record NCT04772313. 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 Phase 4, Multicenter, Open-label, Efficacy and Safety Trial of Pegloticase and Methotrexate Co-administered in Patients With Uncontrolled Gout Who Have Previously Received Pegloticase Monotherapy But Did Not Maintain a Serum Uric Acid Response
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain serum uric acid (sUA) response and/or a clinically mild infusion reaction (IR). Approximately 30 participants will be enrolled. Pegloticase + MTX will be administered for approximately 24 weeks, with an optional extension up to 48 weeks. The trial design will include 5 distinct components: 1. Screening Period, lasting up to 42 days; 2. 6-week MTX Tolerability Assessment Period (hereafter referred to as the MTX Run-in Period); 3. 24-week Pegloticase + MTX Treatment Period, which will include a Week 24/End of Trial/Early Termination Visit (subjects that end MTX and pegloticase treatment prior to the Week 24 will remain on trial for follow up until the Week 24 visit) 4. Optional Pegloticase + MTX Extension Period up to 24 weeks 5. 30-Day Post Treatment Follow -up
Study identification
- NCT ID
- NCT04772313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 11 participants
Conditions and interventions
Conditions
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
- Mar 8, 2021 (Actual)
- Primary completion
- Aug 23, 2022 (Actual)
- Completion
- Apr 24, 2023 (Actual)
- Last update posted
- Jun 27, 2024
2021 – 2023
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) - Center for Education & Research on Therapeutics of Musculoskeletal Disorders | Birmingham | Alabama | 35294-0002 | — |
| Arizona Arthritis and Rheumatology Associates | Flagstaff | Arizona | 86001 | — |
| Arizona Arthritis and Rheumatology Associates | Glendale | Arizona | 85306 | — |
| Arizona Arthritis and Rheumatology Associates | Mesa | Arizona | 85210 | — |
| East Bay Rheumatology Medical Group | San Leandro | California | 94578 | — |
| Providence St. John's Health Clinic | Santa Monica | California | 90404 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045-2536 | — |
| Life Clinical Trials | Margate | Florida | 33063 | — |
| IRIS Research and Development, LLC | Plantation | Florida | 33324 | — |
| Napa Research | Pompano Beach | Florida | 33046 | — |
| GCP Clinical Research, LLC | Tampa | Florida | 33609 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | — |
| Western Washington Arthritis Clinic | Bothell | Washington | 98021 | — |
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 NCT04772313, 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 27, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04772313 live on ClinicalTrials.gov.