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
Condition(s) studied
Investigational drug(s) / intervention(s)
Pegloticase: Participants will receive pegloticase either SC or IV.
Methotrexate: MTX will be administered orally.
Study summary
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.
Eligibility
Primary outcome measure(s)
- Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24 — Month 6 (Weeks 20, 21, 22, 23, and 24)
Defined as Achieving and Maintaining sUA \< 6 mg/dL for at Least 80% of the Time During Month 6.
Trial sites (75)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Orthopedic Physicians Alaska | Anchorage | Alaska | Recruiting |
| Unity Health Searcy Medical Center | Searcy | Arkansas | Recruiting |
| Precision Rheumatology | Anaheim | California | Recruiting |
| Advanced Clinical Research Center, LLC dba TriWest Research Associates | Chula Vista | California | Recruiting |
| Veterans Affairs Long Beach Health Care System | Long Beach | California | Recruiting |
| Solace Clinical Research | Tustin | California | Recruiting |
| Jiva Health | Walnut Creek | California | Recruiting |
| Denver Arthritis Clinic PC | Denver | Colorado | Recruiting |
| Arthritis and Rheumatic Disease Specialties | Aventura | Florida | Recruiting |
| D and H Pompano Research Center | Aventura | Florida | Recruiting |
| Bay Pines Veterans Affairs Healthcare System | Bay Pines | Florida | Recruiting |
| Discovery Health Research Center | Coral Springs | Florida | Recruiting |
| Hillcrest Medical Research | DeLand | Florida | Recruiting |
| New Generation of Medical Research | Hialeah | Florida | Recruiting |
| Homestead Associates In Research Inc | Homestead | Florida | Recruiting |
| Decision Management International Research | Largo | Florida | Recruiting |
| Pharmax Research Clinic | Miami | Florida | Recruiting |
| Well Pharma Medical Research Corp | Miami | Florida | Recruiting |
| D and H National Research Centers | Miami | Florida | Recruiting |
| Advanced Clinical Research | Miami | Florida | Recruiting |
| Entrust Clinical Research | Miami | Florida | Recruiting |
| Felicidad Medical Research | Miami | Florida | Recruiting |
| Integral Rheumatology and Immunology Specialists | Plantation | Florida | Recruiting |
| D and H Tamarac Research Center | Tamarac | Florida | Recruiting |
| Nodal Medical Center Research | Tampa | Florida | Recruiting |
| ClinPro Research Solutions LLC | Tampa | Florida | Recruiting |
| GCP Clinical Research, LLC | Tampa | Florida | Recruiting |
| Conquest Research - Winter Park | Winter Park | Florida | Recruiting |
| Spatium Urgent Care | Marietta | Georgia | Recruiting |
| Vista Clinical Research | Newnan | Georgia | Recruiting |
| Greater Chicago Specialty Physicians | Boise | Idaho | Recruiting |
| Saint Lukes Intermountain Research Center | Meridian | Idaho | Recruiting |
| Charter Research | Chicago | Illinois | Recruiting |
| Flourish Research Ravenswood | Chicago | Illinois | Recruiting |
| Willow Rheumatology and Wellness | Willowbrook | Illinois | Recruiting |
| Clinical Trials Management, LLC, d/b/a Flourish Research | Mandeville | Louisiana | Recruiting |
| Kur Research at Columbia Medical Practice | Columbia | Maryland | Recruiting |
| MD Medical Research | Oxon Hill | Maryland | Recruiting |
| June DO PC | Lansing | Michigan | Recruiting |
+ 35 more sites — see the full list on the official registry below.
More Amgen trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07388498 on ClinicalTrials.gov ↗ ← All trials in the USA