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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,881-participant average among 34 other Gout trials with a reported enrollment target (97% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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