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NCT06229145 · ClinicalTrials.gov registry record · 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
A Phase 4 study of Gout, sponsored by Amgen.
- Active
- Registry status
- Phase 4
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT06229145: Active Phase 4 study of Gout, sponsored by Amgen.
NCT06229145 is a Phase 4 study of Gout that is active but no longer recruiting, run by Amgen. The registered enrollment target is 262 participants, below the 8,881-participant average among 34 other Gout trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06229145, a Phase 4 study of Gout, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Responders were defined as participants who achieved and maintained sUA levels below 6 mg/dL for at least 80% of the time during Month 6. Responders who met sUA discontinuation criteria (2 consecutive sUA \> 6 mg/dL), regardless of treatment status were considered non-responders.
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
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2024-03-18 |
| Est. Completion | 2026-03-12 |
| Phase | Phase 4 |
What the registry record for NCT06229145 still lists
NCT06229145 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 8,881-participant average among 34 other Gout trials with a reported enrollment target (97% lower).
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.
NCT06229145 names 20 study sites across 4 states, led by Arizona, California, Alabama.
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.
What interventions are being tested in trial NCT06229145?
The interventions under investigation include: Methotrexate (DRUG), Pegloticase (BIOLOGICAL).
Who is sponsoring clinical trial NCT06229145?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06229145's enrollment target sits among peer trials
262 10th of 34 higher than 25 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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