A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
Public ClinicalTrials.gov record NCT04762498. 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, 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04762498
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Jan 26, 2021 (Actual)
- Primary completion
- May 18, 2023 (Actual)
- Completion
- Dec 20, 2023 (Actual)
- Last update posted
- May 19, 2026
2021 – 2023
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orthopedic Physicians Alaska | Anchorage | Alaska | 99508 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Glendale | Arizona | 85306 | — |
| East Bay Rheumatology Medical Group, Inc. | San Leandro | California | 94578 | — |
| ProHealth Research Center | Doral | Florida | 33166 | — |
| Napa Research Center | Pompano Beach | Florida | 33064 | — |
| GCP Clinical Research | Tampa | Florida | 33064 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| Shelby Clinical Research, LLC | Shelby | North Carolina | 28150 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | — |
| Arthritis Clinic: Western Washington Medical Group | Bothell | Washington | 98021 | — |
| Arthritis Northwest PLLC | Spokane | Washington | 99204 | — |
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 NCT04762498, 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 May 19, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04762498 live on ClinicalTrials.gov.