Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Uncontrolled Gout, sponsored by Amgen.
NCT04772313 is a Phase 4 study of Uncontrolled Gout that has completed, run by Amgen. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
An sUA responder is defined as a participant achieving and maintaining sUA \<6 mg/dL for at least 80% of the time during Month 6 (Weeks 20, 21, 22, 23 and 24).
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 |
What the finished NCT04772313 record still lists
NCT04772313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
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 lists 15 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Uncontrolled 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 NCT04772313's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
RECRUITING · Phase 2
-
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI