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
Public ClinicalTrials.gov record NCT06229145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06229145
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 306 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 18, 2024 (Actual)
- Primary completion
- Jul 30, 2025 (Actual)
- Completion
- Mar 26, 2026 (Actual)
- Last update posted
- Sep 17, 2026
2024 – 2026
United States locations
- U.S. sites
- 74
- U.S. states
- 23
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35233 | — |
| Orthopedic Physicians Alaska - Rheumatology and Infusion | Anchorage | Alaska | 99508-5234 | — |
| Arizona Arthritis and Rheumatology Associates - Chandler | Chandler | Arizona | 85225-2915 | — |
| Arizona Arthritis and Rheumatology Rese | Flagstaff | Arizona | 86001 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Gilbert | Arizona | 85297 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Mesa | Arizona | 85032 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Mesa | Arizona | 85210 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85037-4403 | — |
| Arizona Arthritis and Rheumatology Research | Phoenix | Arizona | 85037 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Sun City | Arizona | 85351 | — |
| Arizona Arthritis and Rheumatology | Tucson | Arizona | 85704 | — |
| Covina Arthritis Clinic | Covina | California | 91722 | — |
| Medvin Clinical Research- Riverside | Hemet | California | 92543 | — |
| Velocity Clinical Research - Boise - ERN - PPDS | North Hollywood | California | 83642 | — |
| TriWest Research Associates | San Diego | California | 92108 | — |
| Precision Comprehensive Clinical Research Solutions | San Leandro | California | 94578-2630 | — |
| Saint John's Health Center - Providence St John's Health Ctr | Santa Monica | California | 90404 | — |
| C.V. Mehta MD Medical Corporation | Temecula | California | 92592 | — |
| Foothill Arthritis | Tujunga | California | 91042 | — |
| Medvin Clinical Research | Whittier | California | 90602 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80918 | — |
| Denver Arthritis Clinic - Rheumatology | Denver | Colorado | 80230 | — |
| Arthritis & Rheumatic Disease | Aventura | Florida | 33180-1204 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| Life Clinical Trials | Margate | Florida | 33063-5675 | — |
| Homestead Associates in Research,Inc | Miami | Florida | 33032-8225 | — |
| D&H National Research Centers, Inc. | Miami | Florida | 33155 | — |
| Well Pharma | Miami | Florida | 33173 | — |
| Felicidad Medical Research, LLC. | Miami | Florida | 33184 | — |
| New Generation Of Medical Research | Naples | Florida | 34104 | — |
| IRIS Research & Development | Plantation | Florida | 33324 | — |
| D&H Pompano Research Center | Pompano Beach | Florida | 33064 | — |
| D&H Tamarac Research Center | Tamarac | Florida | 33321 | — |
| GCP Clinical Research | Tampa | Florida | 33609 | — |
| ClinPro Research Solutions, LLC | Tampa | Florida | 33613 | — |
| Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | — |
| Vista Clinical Research, LLC | Newnan | Georgia | 30265 | — |
| Great Lakes Clin. Trials | Chicago | Illinois | 60625 | — |
| Conquest Research - Anesthesiology/Pain Medicine | Chicago | Illinois | 60637 | — |
| Great Lakes Clinical Trials - Gurnee | Highland Park | Illinois | 60035 | — |
| Crowley CORE - Illinois Bone and Joint Institute | Hinsdale | Illinois | 60521 | — |
| Lake Cumberland Rheumatology, PLLC | New Albany | Indiana | 47150 | — |
| L-MARC Research Center | Louisville | Kentucky | 40213 | — |
| Velocity CR - New Orleans | Covington | Louisiana | 70433 | — |
| Velocity CR - New Orleans | New Orleans | Louisiana | 70121-2429 | — |
| Michigan Medicine | Ann Arbor | Michigan | 48109 | — |
| June DO,PC | Lansing | Michigan | 48911 | — |
| Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | 48081 | — |
| Inspire Santa Fe Medical Group | Santa Fe | New Mexico | 87505 | — |
| Velocity Clinical Research-Vestal | Vestal | New York | 13850 | — |
| OnSite Clinical Solutions, LLC | Charlotte | North Carolina | 28226 | — |
| Research Carolina Elite | Denver | North Carolina | 28037 | — |
| Triad Clinical Trials - Gastroenterology | Greensboro | North Carolina | 27410 | — |
| Accellacare of Hickory | Hickory | North Carolina | 28602 | — |
| Cape Fear Arthritis Care | Leland | North Carolina | 28451-4168 | — |
| Shelby Clinical Research - Family Medicine | Shelby | North Carolina | 28152 | — |
| Velocity Clinical Research- Cincinatti | Cincinnati | Ohio | 45242 | — |
| Velocity Clinical Research - Cleveland | Cleveland | Ohio | 44122 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73111-3324 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Velocity Clinical Research, Spartanburg - Pulmonology | Greenville | South Carolina | 29615 | — |
| Premier Clinics Pa - Rock Hill, Sc | Rock Hill | South Carolina | 29732 | — |
| Low Country Rheumatology | Summerville | South Carolina | 29486-7887 | — |
| Amarillo Center for Clinical Research, Ltd. | Amarillo | Texas | 79124 | — |
| Clinical Trial Network | Austin | Texas | 78750 | — |
| Synergy Groups Medical LLC | Houston | Texas | 77061 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77099 | — |
| AIM Trials - Internal Medicine | Plano | Texas | 75093 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Texas Research Center | Sugar Land | Texas | 77479 | — |
| Velocity Clinical Research - Salt Lake City (West Jordan) | West Jordan | Utah | 84088 | — |
| Velocity Clinical Research-Portsmouth | Portsmouth | Virginia | 23703-3200 | — |
| Arthritis Northwest, PLLC - Research | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06229145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 17, 2026 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06229145 live on ClinicalTrials.gov.