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ACTIVE NOT RECRUITING Phase 4

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

NCT06229145 · View on ClinicalTrials.gov ↗

Study Summary

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \< 6 mg/dL for at least 80% of the time.

Conditions Studied

Interventions

  • DRUG Methotrexate
  • BIOLOGICAL Pegloticase

Study Locations (20)

Arizona

  • Arizona Arthritis and Rheumatology Associates - Chandler — Chandler
  • Arizona Arthritis and Rheumatology Rese — Flagstaff
  • Arizona Arthritis & Rheumatology Research, PLLC — Gilbert
  • Arizona Arthritis & Rheumatology Research, PLLC — Mesa
  • Arizona Arthritis and Rheumatology Research, PLLC — Mesa
  • Arizona Arthritis and Rheumatology Research, PLLC — Phoenix
  • Arizona Arthritis and Rheumatology Research — Phoenix
  • Arizona Arthritis & Rheumatology Research, PLLC — Sun City
  • Arizona Arthritis and Rheumatology — Tucson

California

  • Covina Arthritis Clinic — Covina
  • Medvin Clinical Research- Riverside — Hemet
  • Velocity Clinical Research - Boise - ERN - PPDS — North Hollywood
  • TriWest Research Associates — San Diego
  • Precision Comprehensive Clinical Research Solutions — San Leandro
  • Saint John's Health Center - Providence St John's Health Ctr — Santa Monica
  • C.V. Mehta MD Medical Corporation — Temecula
  • Foothill Arthritis — Tujunga
  • Medvin Clinical Research — Whittier

Alabama

  • The University of Alabama at Birmingham (UAB) — Birmingham

Alaska

  • Orthopedic Physicians Alaska - Rheumatology and Infusion — Anchorage

Trial Details

FieldValue
Enrollment Target 262 participants
Start Date 2024-03-18
Est. Completion 2026-03-12
Phase Phase 4

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06229145

The ClinicalTrials.gov registry entry for NCT06229145 describes a study currently listed as active not recruiting. 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 262 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 Gout appearing as the primary indexed condition, and to 2 interventions — of which Methotrexate 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: NCT06229145 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Arizona, California, Alabama. 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 NCT06229145 about?

NCT06229145 is a clinical study titled "A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout". The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The mai...

What is the current status of trial NCT06229145?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 262 participants. The study started on 2024-03-18. Estimated completion is 2026-03-12.

What conditions does trial NCT06229145 study?

This clinical trial studies the following conditions: 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 NCT06229145?

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

Who is sponsoring clinical trial NCT06229145?

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 NCT06229145 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, California. 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