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The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
Approximately 180 participants will be enrolled. After a 4-week methotrexate run-in period, participants will be treated for up to 24 weeks with weekly oral methotrexate and biweekly 8mg pegloticase infusions. Up to three pegloticase infusion durations will be assessed in the study: 60-minute infusion, 45-minute infusion and 30-minute infusion. Safety evaluations will be performed regularly throughout the course of the study.
Acquired from Horizon in 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegloticase 60 Minute Infusion with methotrexate (MTX) | Experimental | Pegloticase 60 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks |
|
| Pegloticase 45 Minute Infusion with methotrexate (MTX) | Experimental | Pegloticase 45 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks |
|
| Pegloticase 30 Minute Infusion with methotrexate (MTX) | Experimental | Pegloticase 30 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegloticase with MTX | Biological | Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24 | IRs, including anaphylaxis, were assessed after each infusion for a period of 24 weeks. IRs were defined as any infusion-related adverse event (AE) or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and up to 2 hours post-infusion. Additional AEs occurring outside of the 2-hour window following infusion could also be categorized as an IR at the Principal Investigator's discretion. | Day 1 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Serum Uric Acid (sUA) Responders at Month 6 | Responders were defined as participants who achieved and maintained sUA levels below 6 mg/dL for at least 80% of the time during month 6. Responders who met sUA discontinuation criteria (2 consecutive sUA > 6 mg/dL), regardless of treatment status were considered non-responders. | Up to 6 months |
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Inclusion Criteria:
Adult men or women ≥18 years of age.
Uncontrolled gout, defined as meeting the following criteria:
Hyperuricemia during the screening period defined as sUA ≥6 mg/dL
Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with intolerable side effects or a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview.
Symptoms of gout including at least 1 of the following:
Willing to discontinue all oral urate-lowering therapy at least 7 days prior to MTX dosing at Week -4 and remain off of urate lowering therapy when receiving pegloticase infusions during the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Orthopedic Physicians Alaska |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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A 4-week methotrexate (MTX) run-in period, with a weekly dose of 15 mg, was used to identify screening failures due to MTX intolerance. All participants who completed the run-in period received their first dose of pegloticase on Day 1, followed by additional doses every 2 weeks (Q2W) for a total of 22 weeks.
Participants with uncontrolled gout were enrolled at 36 centers across the United States between October 2020 and March 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegloticase 60 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
| FG001 | Pegloticase 45 Minute + MTX |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 9, 2022 | Dec 12, 2024 |
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Three different infusion durations may be used. 60-minute infusion, 45-minute infusion and 30-minute.
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|
| Percentage of Participants Who Experienced an IR Leading to Discontinuation of Treatment, Anaphylaxis or Met sUA Discontinuation Criteria | IRs were defined as any infusion-related AE or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and for 2 hours post-infusion. Other AEs that occurred outside of the 2 hour window following the infusion may have also been categorized as an IR at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual sUA discontinuation criteria was defined as two consecutive pre-infusion sUAs > 6 mg/dL after Day 1. | Day 1 to Week 24 |
| Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in All Participants | Infusion reactions were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1. Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. All participants were censored at the date of their last infusion. | Day 1 to Week 24 |
| Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in Participants With an Event | IRs were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1. Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. Only participants who experienced an event were included in this analysis. | Day 1 to Week 24 |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Arizona Arthritis & Rheumatology Research | Gilbert | Arizona | 85297 | United States |
| Arthritis & Rheumatology Research | Mesa | Arizona | 85210 | United States |
| Arizona Arthritis & Rheumatology Research | Phoenix | Arizona | 85037 | United States |
| Medvin Clinical Research | Covina | California | 91722 | United States |
| Amicis Research Center | Northridge | California | 91324 | United States |
| Providence Saint John's Health Center | Santa Monica | California | 90404 | United States |
| Medvin Clinical Research | Thousand Oaks | California | 91360 | United States |
| Medvin Clinical Research | Tujunga | California | 91042 | United States |
| University of Colorado Division of Rheumatology | Aurora | Colorado | 80045 | United States |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | United States |
| Bradenton Research Center | Bradenton | Florida | 34205 | United States |
| Prohealth Research Center | Doral | Florida | 33166 | United States |
| LIFE Clinical Trials | Margate | Florida | 33063 | United States |
| D&H National Research Centers | Miami | Florida | 33155 | United States |
| IRIS Research and Development, LLC | Plantation | Florida | 33324 | United States |
| Napa Research Center | Pompano Beach | Florida | 33064 | United States |
| D&H Tamarac Research Centers | Tamarac | Florida | 33321 | United States |
| GCP Clinical Research | Tampa | Florida | 33064 | United States |
| ClinPro Research Solutions | Tampa | Florida | 33609 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| MD Medical Research | Oxon Hill | Maryland | 20745 | United States |
| Santa Fe Rheumatology | Santa Fe | New Mexico | 87505 | United States |
| Long Island Arthritis & Osteoporosis Care | Babylon | New York | 11702 | United States |
| Research Carolina Elite | Denver | North Carolina | 28037 | United States |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28602 | United States |
| Cape Fear Arthritis Care | Leland | North Carolina | 28451 | United States |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | United States |
| Shelby Clinical Research, LLC | Shelby | North Carolina | 28150 | United States |
| Velocity Clinical Research Cincinnati | Cincinnati | Ohio | 45242 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Chattanooga Research & Medicine PLLC (CHARM) | Chattanooga | Tennessee | 37404 | United States |
| Abigail Rebecca Neiman, MD, PA | Houston | Texas | 77024 | United States |
| Pioneer Research Solutions Inc - Houston | Houston | Texas | 77099 | United States |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | United States |
| Western Washington Medical Group | Bothell | Washington | 98021 | United States |
| Arthritis Northwest | Spokane | Washington | 99204 | United States |
Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.
| FG002 | Pegloticase 30 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Modified intent-to-treat (mITT) Analysis Set: All participants who received at least 1 dose of pegloticase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegloticase 60 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
| BG001 | Pegloticase 45 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
| BG002 | Pegloticase 30 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced an Infusion Reaction (IR), Including Anaphylaxis, Related to Pegloticase From Day 1 to Week 24 | IRs, including anaphylaxis, were assessed after each infusion for a period of 24 weeks. IRs were defined as any infusion-related adverse event (AE) or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and up to 2 hours post-infusion. Additional AEs occurring outside of the 2-hour window following infusion could also be categorized as an IR at the Principal Investigator's discretion. | Safety Analysis Set (SAS): All participants who received at least 1 dose of pegloticase. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 to Week 24 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Serum Uric Acid (sUA) Responders at Month 6 | Responders were defined as participants who achieved and maintained sUA levels below 6 mg/dL for at least 80% of the time during month 6. Responders who met sUA discontinuation criteria (2 consecutive sUA > 6 mg/dL), regardless of treatment status were considered non-responders. | mITT Analysis Set: All participants who received at least 1 dose of pegloticase. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 6 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced an IR Leading to Discontinuation of Treatment, Anaphylaxis or Met sUA Discontinuation Criteria | IRs were defined as any infusion-related AE or cluster of temporally-related AEs, not attributable to another cause, which occurred during the pegloticase infusion and for 2 hours post-infusion. Other AEs that occurred outside of the 2 hour window following the infusion may have also been categorized as an IR at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual sUA discontinuation criteria was defined as two consecutive pre-infusion sUAs > 6 mg/dL after Day 1. | SAS: All participants who received at least 1 dose of pegloticase. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 to Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in All Participants | Infusion reactions were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1. Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. All participants were censored at the date of their last infusion. | SAS: All participants who received at least 1 dose of pegloticase. | Posted | Median | 95% Confidence Interval | Days | Day 1 to Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First Event of IR Leading to Discontinuation of Treatment, Anaphylaxis or Meeting sUA Discontinuation Criteria in Participants With an Event | IRs were defined as any infusion-related adverse event or cluster of temporally-related adverse events, not attributable to another cause, which occurred during the infusion and for 2 hours post-infusion. Other adverse events that occurred outside of the 2-hour window following the infusion may have also been categorized as an infusion reaction at the Principal Investigator's discretion. Anaphylaxis was defined using the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network criteria. Meeting individual serum uric acid discontinuation criteria was defined as two consecutive pre-infusion serum uric acid levels greater than 6 mg/dL after Day 1. Time to event was derived as the date of the event minus the date of the first dose of the treatment plus 1. Only participants who experienced an event were included in this analysis. | All participants who received at least 1 dose of pegloticase and experienced an IR leading to discontinuation of treatment, anaphylaxis or met sUA discontinuation criteria. | Posted | Median | Full Range | Days | Day 1 to Week 24 |
|
Up to approximately 1 year.
A 4-week MTX run-in period (15 mg weekly) was conducted to identify screening failures due to MTX intolerance. Of 215 participants receiving MTX, 24 discontinued before receiving pegloticase and were deemed screen failures. The remaining 191 participants completed the run-in period, received pegloticase on Day 1, and were considered enrolled in the trial. All enrolled participants received the first pegloticase dose on Day 1, followed by additional doses Q2W for a total of 22 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MTX Run-In | MTX Run-In Period | 0 | 215 | 1 | 215 | 79 | 215 |
| EG001 | Pegloticase 60 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 60-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. | 0 | 116 | 4 | 116 | 86 | 116 |
| EG002 | Pegloticase 45 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. | 0 | 13 | 0 | 13 | 13 | 13 |
| EG003 | Pegloticase 30 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. | 0 | 62 | 5 | 62 | 46 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Shigella infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Scrotal swelling | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2024 | Dec 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031545 | Pegloticase |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than 1 race |
|
| Other |
|
| Not Hispanic or Latino |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Pegloticase 30 Minute + MTX |
Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
|
|
| OG002 | Pegloticase 30 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
|
|
Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 45-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks.
| OG002 | Pegloticase 30 Minute + MTX | Participants received oral MTX (15 mg) (weekly) during the Run-in Period, then 30-minute pegloticase IV infusions (every 2 weeks) with MTX (weekly) for 24 weeks. |
|
|