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NCT04772313 · ClinicalTrials.gov registry record · Phase 4
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
A Phase 4 study of Uncontrolled Gout, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
- 15
- Study locations
NCT04772313 is a Phase 4 study of Uncontrolled Gout that has completed, run by Amgen. The registered enrollment target is 11 participants. The trial reports 15 study locations across 9 states.
The verdict
NCT04772313, a Phase 4 study of Uncontrolled Gout, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
- 15
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2023-04-24 |
| Phase | Phase 4 |
Interested in This Trial?
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, categorized as Phase 4. 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 558 total studies on file at ClinicalTrials.gov.
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.
NCT04772313 reports 15 study locations spanning 9 distinct geographic areas - top geographies include Florida, Arizona, California.
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.
What interventions are being tested in trial NCT04772313?
The interventions under investigation include: Methotrexate (MTX) (DRUG), Pegloticase (BIOLOGICAL).
Who is sponsoring clinical trial NCT04772313?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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