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COMPLETED Phase 4

Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy

NCT04772313 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • DRUG Methotrexate (MTX)
  • BIOLOGICAL Pegloticase

Study Locations (15)

Florida

  • Life Clinical Trials — Margate
  • IRIS Research and Development, LLC — Plantation
  • Napa Research — Pompano Beach
  • GCP Clinical Research, LLC — Tampa

Arizona

  • Arizona Arthritis and Rheumatology Associates — Flagstaff
  • Arizona Arthritis and Rheumatology Associates — Glendale
  • Arizona Arthritis and Rheumatology Associates — Mesa

California

  • East Bay Rheumatology Medical Group — San Leandro
  • Providence St. John's Health Clinic — Santa Monica

Alabama

  • University of Alabama at Birmingham (UAB) - Center for Education & Research on Therapeutics of Musculoskeletal Disorders — Birmingham

Colorado

  • University of Colorado Anschutz Medical Campus — Aurora

Maryland

  • The Center for Rheumatology and Bone Research — Wheaton

Pennsylvania

  • Altoona Center for Clinical Research — Duncansville

Texas

  • Biopharma Informatic, LLC — Houston

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2021-03-08
Est. Completion 2023-04-24
Phase Phase 4

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04772313

The ClinicalTrials.gov registry entry for NCT04772313 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Uncontrolled Gout appearing as the primary indexed condition, and to 2 interventions — of which Methotrexate (MTX) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04772313 reports 15 study locations spanning 9 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04772313 about?

NCT04772313 is a clinical study titled "Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy". 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 an...

What is the current status of trial NCT04772313?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2021-03-08. Estimated completion is 2023-04-24.

What conditions does trial NCT04772313 study?

This clinical trial studies the following conditions: Uncontrolled Gout. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04772313?

The interventions under investigation include: Methotrexate (MTX) (DRUG), Pegloticase (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04772313?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04772313 being conducted?

This trial has 15 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial